2018 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.
Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
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Plasmalink Bottle with Locking Luer Adapter Empty Containers for the Collection & Processing of Blood/Blood Components |
The Plasma Pooling Bottle is used for the collection, storage, and shipment of plasma prior to fractionation. | BK180293/0 | Fresenius Kabi AG Three Corporate Dr, Lake Zurich, IL 60047, US |
12/21/2018 |
Erytra Eflexis Automated Blood Grouping and Antibody Test Systems |
Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. |
BK180260/0 | Diagnostic Grifols, S. A. Passeig Fluvial, 24, Parets Del Valles, 08150 SP |
12/20/2018 |
Glycerolyte 57 Solution, 400 mL Glycerolyte 57 Solution, 500 mL Processing Systems for Frozen Blood |
A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion. Glycerolyte 57 Solution: Glycerolyte 57 Solution is a high concentration glycerol cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Modifications to the kits associated with this 510(k) are not intended to add, delete, or modify information as described in labeling regarding the intended use of the device or the disposable kits. |
BK180254/0 | BK180254/0 Fresenius Kabi AG Three Corporate Dr, Lake Zurich, IL 60047, US |
12/03/2018 |
BACT/ALERT® BPA Culture Bottle BACT/ALERT® BPN Culture Bottle Bacterial Detection Systems for Platelet Transfusion Products |
BPA Culture Bottle BACT/ALERT® BPA culture bottles are used with the BACT/ALERT® Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BACT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi). |
BK180266/0 | bioMerieux, Inc. 595 Anglum Road, Hazelwood, MO 63042 |
11/29/2018 |
Leukocyte Reduction Filter for Red Blood Cells Empty Containers for the Collection & Processing of Blood/Blood Components |
The Leukocyte Reduction Filter for Red Blood Cells is indicated for the leukoreduction of a single unit of red blood cells collected from a blood donor at ambient temperature (20 to 24 ºC) within 8 hours, or refrigerated at (1 to 6 ºC) not later than 7 days after collection. | BK180188/0 | PuriBlood Medical Co. Ltd. 2F., No.11, Gongye E. 9th Rd., Hsinchu Hsien, 30075, TW |
11/23/2018 |
OriGen Cryostore Multi-Chamber Freezing Bags Empty Containers for the Collection & Processing of Blood/Blood Components |
The Cryostore bag is designed to cryogenically freeze blood components. This product is for single use only, contraindicated for other uses. Contains no Phthalates, BPA or latex. | BK180278/0 | OriGen BioMedical, Inc. Emergo Global Consulting, LLC Building 1, Suite 300, 2500 Bee Cave Road, Austin, TX 78746 |
11/21/2018 |
Healeon PRP Platelet Preparation System Platelet And Plasma Separator For Bone Graft Handling |
The HM-PRP KIT is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK170136/0 | Healeon Medical, Inc. 1111 Rancho Conejo Blvd #204, Newbury Park, CA 91320 |
11/21/2018 |
Capture-CMV CMV Tests for Donors |
The Immucor Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of donors or patients for serological evidence of previous infection by CMV. | BK180247/0 | Immucor, Inc. 3130 Gateway Drive, Norcross, GA 30071 |
11/20/2018 |
AXP II AutoXpress Platform Cord blood processing system and storage container |
The ThermoGenesis AXP II AutoZpress Platform is a cord blood processing system intended for laboratory use in conjunction with a specific single-use separation kit supplied by ThermoGenesis. The AXP II system allows the fast, automated, and reproducible separation of cord blood in a closed and sterile environment. | BK180198/0 | ThermoGenesis Corp 2700 Citrus Rd, Ranco Cordova, CA 75741 |
11/14/2018 |
Instrument Manager 8.16.10 Blood Establishment Computer Software and Accessories |
Instrument Manager is a stand-alone software application for use in a blood establishment that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the display and management of laboratory results. Instrument manager provides system checks to prevent Patient ID and Specimen ID mismatches and provides the capability for user enabled rules which can be configured to hold results for verification before they can be released. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. | BK180245/0 | Data Innovations LLC 120 Kimball Ave., Suite 100, South Burlington, VT 05430 |
11/08/2018 |
Neo Iris Version 3 Automated Blood Grouping and Antibody Test Systems |
Automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification ofigG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). | BK180243/0 | Immucor, Inc. 3130 Gateway Drive, Norcross, GA 30071 |
11/07/2018 |
GDS (Grifols Donation System) 1.0 Blood Establishment Computer Software and Accessories |
GDS (acronym for Grifols Donation System), version 1.0, is an application designed to manage plasma donor center activities such as donor eligibility, unit suitability, shipments (units and samples), sample management, deviation management, equipment management and supplies management. GDS software provides management controls and information services modules that have been designed to assist personnel in the operational core functions in the company's plasma donor centers. | BK180240/0 | Biomat USA, Inc. 2410 Lillyvale Ave, Los Angeles, CA 90032 |
11/05/2018 |
Aurora XI Plasmapheresis System/Aurora XI System/Aurora XI 1.2 Automated Blood Cell Separators |
The Aurora Xi Plasmapheresis System is intended for the automated collection of plasma by membrane filtration to be processed as Source Plasma. The Aurora Xi system is to be used with a single-use PLASMACELL Xi disposable set and 4% sodium citrate anticoagulant, and allows for Saline and No Saline Protocol options. | BK180268/0 | Fresenius Kabi AG Three Corporate Dr, Lake Zurich, IL 60047 |
11/02/2018 |
Blood Bank Information System v2.06.00 Blood Establishment Computer Software and Accessories |
Blood Bank Information Management System (BBIMS) v2.06.00 is a Blood Establishment Computer System that is intended for use by trained healthcare professionals for the following blood manufacturing activities:
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BK180246/0 | Carter BloodCare 2205 Highway 121, Bedford, TX 76021, US |
11/01/2018 |
Patient Health Software (P.H.S) Version 2.0 Blood Establishment Computer Software and Accessories |
The Patient Health Software (PHS) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to: blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. PHS is designed to aid and assist qualified and trained personnel to support the operations within their facilities. PHS software supports single, centralized multi-sites and multi-organizations to be used centrally or in stand-alone. |
BK180232/0 |
MAK-SYSTEM SA International Group 10 Avenue de la Grande-Armee, |
10/18/2018 |
Molecular erythrocyte typing test |
ID CORE XT (Reagents and ANALYSIS SOFTWARE) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding HEAs in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms that predict 53 HEA alleles and 37 antigens of the blood group systems Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright, and Lutheran. | BP170154/0 |
Progenika Biopharma, S.A. Ibaizabal bidea, |
10/11/2018 |
Quality control for molecular immunohematology tests |
The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL I and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2) of the 29 polymorphisms interrogated by ID CORE XTTM. Both control vials must be used in every run of the ID CORE XT test. |
BK170092/0 |
Progenika Biopharma, S.A. Ibaizabal bidea, |
10/11/2018 |
Blood Mixing and blood weighing device |
HemoMix 3 with optional DCSX Software is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached. | BK180229/0 |
Delcon S.R.L Via Zanica, |
10/04/2018 |
VistA Blood Establishment Computer Software (VBECS) Version 2.3.0 Blood Establishment Computer Software and Accessories |
VistA Blood Establishment Computer Software (VBECS) is a computer software application that manages transfusion service activities. The purpose of VBECS is to automate the documentation and record keeping of selected daily activities of the transfusion service. |
BK180227/0 |
Department of Veterans Affairs P.O Box 7008, |
10/01/2018 |
IH-Com V5.0 Automated Blood Grouping and Antibody Test Systems |
IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for blood samples that are tested on the IH-1000 and IH-Reader 24 with IH-System reagents or the TANGO infinity® with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with:
IH-Com V5.0 should only be operated by trained personnel and is not intended for use in a direct patient environment. In the USA IH-Com V5.0 is “Rx only”. |
BK180226/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, 63303, GM |
9/28/2018 |
IH-Reader 24 Automated Blood Grouping and Antibody Test Systems |
The IH-Reader 24 is an instrument intended for the in vitro serological analysis of human blood specimens for blood grouping and antibody detection. IH-Reader 24 performs centrifugation and provides reaction grading / interpretation based on results from IH-System gel card images. In the USA, IH-Reader 24 is "Rx only".
The IH-Reader 24 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-Reader 24 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. IH-Reader 24 is allowed to use gel cards from the IH-System authorized by Bio-Rad. The use of any material not specified in the User Manual (e.g. non-authorized substances) is under the users' responsibility. |
BK180225/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, 63303, GM |
9/28/2018 |
RECELL® Autologous Cell Harvesting Device | The ReCell® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older. The RECELL® Device is used by an appropriately-licensed healthcare professional at the patient’s point-of-care to prepare autologous Regenerative Epidermal Suspension(RESTM) for direct application to acute partial-thickness thermal burn wounds or application in combination with meshed autografting for acute full-thickness thermal burn wounds. | BP170122/0 | Avita Medical Americas, LLC 28159 Avenue Stanford, Suite 220 Valencia, CA, 91355-2271 |
9/20/2018 |
MEDITECH Expanse Blood Bank Blood Establishment Computer Software and Accessories |
The MEDITECH Blood Bank Software provides a variety of functionality for healthcare personnel. The software helps personnel, in both multiple and single facility organizations, manage their departments more efficiently by integrating donor, unit, and patient information. The MEDITECH Blood Bank Software assists with:
The MEDITECH Blood Bank Software interfaces to the following Blood Bank Analyzer for the purposes of specimen resulting and transmitting the results to the MEDITECH Blood Bank Software: Galileo Echo The software also allows online inquiries and permanent storage of:
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BK180219/0 | Medical Information Technology, Inc. Meditech Circle Westwood, MA 02090 |
9/12/2018 |
Trima Accel® Automated Blood Collection System Automated Blood Cell Separators |
The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients. Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:
Or the following products alone or in combination:
Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. Platelets Pheresis, Leukocyte Reduced, Platelet Additive Solution (Isoplate) (single or double units) may be further processed (e.g., irradiated, divided). Platelets Pheresis, Platelet Additive Solution (Isoplate) (single or double units) may not be manufactured from products that do not meet leukocyte reduction product standards. The storage conditions of the Trima Platelet bag (ELP bag) have been verified for storage up to 7 days post-collection in 100 % Plasma and up to 5 days in Isoplate Solution (PAS-F). Additionally, for storage up to 7 days, every product must be tested with a bacterial detection device cleared by FDA and labeled as a “safety measure.” The Trima Blood Component Sampling Assembly, which is either integrated into the disposable tubing sets or as an accessory for sterile connection, is intended to allow aseptic removal of a sample from the platelet bag for subsequent bacterial or other applicable testing. The Sampling Assembly does not have contact with blood fluids that are reinfused to a donor or patient.
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BK180231/0 | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 |
8/17/2018 |
DXT Data Management System 3.1 Automated Blood Cell Separators |
DXT is intended to be used in blood establishments to facilitate networked communication between DXT compatible Fresenius Kabi apheresis devices and BECS or other Data Management Systems. The system can be used for electronic record documentation and remote procedure setup to pre-populate procedure parameters on the appropriate instrument. The information available in the system or provided to BECS or other data management systems can be used for medical decision making such as donor deferral/eligibility decisions. DXT can be deployed with apheresis instruments only as stand-alone or as a middleware application to communicate with an existing external system, e.g., BECS and/or data management systems and an apheresis device. | BK180230/0 | Fresenius Kabi AG Three Corporate Dr, Lake Zurich, IL 60047 |
8/14/2018 |
BD BACTEC™ Platelet Aerobic/F Culture vials BD BACTEC™ Platelet Anaerobic/F Culture Vials Microbial growth monitor |
BD BACTEC™ Platelet Aerobic/F Culture vials are used with the BD BACTEC™ FX instrument series for quality control of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Aerobic/F Culture vials support the growth of aerobic microorganisms (bacteria and fungi). BD BACTEC™ Platelet Anaerobic/F Culture Vials are used with the BD BACTEC™ FX instrument series for quality control of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Anaerobic/F Culture Vials support the growth of anaerobic microorganisms. |
BK180211/0 | Becton, Dickinson & Company 7 Loveton Circle, MC 694 Sparks, MD 21152-0999 |
8/8/2018 |
Safe Trace Tx 4.0.0 Blood Establishment Computer Software and Accessories |
SafeTrace Tx is an electronic information system used by single-site, multi-site and centralized transfusion services to manage the blood transfusion process. It manages and tracks blood product information from receipt to final shipment and disposition. SafeTrace Tx is an electronic information system that manages the blood transfusion process and assists in the determination of the suitability of released products. It manages and tracks blood product information relating to receipt, reservation, modification, testing, and final shipment and disposition. The application manages and provides a centralized view of patient, visit, and order information, including positive patient identification and patient, testing and transfusion history. The system can perform electronic crossmatching and safety and compatibility checks between patient and product. Component attributes, such as human leukocyte antigen (HLA) attributes, can be entered into SafeTrace Tx. SafeTrace Tx can operate stand-alone or interface with:
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BK180209/0 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 |
8/7/2018 |
Galileo Echo® Automated Blood Grouping and Antibody Test Systems |
The Galileo Echo® is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo® automates test processing, result interpretation and data management functions. The Galileo Echo® is designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh(D) typing, detection/ identification of IgG red blood cell antibodies, compatibility testing and red blood cell phenotyping. The Galileo Echo® is for in vitro diagnostic use. |
BK180220/0 | Immucor, Inc. 3130 Gateway Drive, Norcross, GA 30091 |
7/17/2018 |
Royal MaxxPRP Concentration System Platelet And Plasma Separator For Bone Graft Handling |
The Royal MaxxPRP Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. | BK180204/0 | Royal Biologics LLC 190 Columbus Drive, Suite #2A Jersey City, NJ 07302 |
7/12/2018 |
Arthrex Angel System Kit Platelet and Plasma Separator For Bone Graft Handling |
The Arthrex Angel System Kits are to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The platelet rich plasma and platelet rich plasma are mixed with autograft and /or allograft bone prior to application to a bony defect for improving handling characteristics. | BK180180/0 | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 |
7/5/2018 |
LifeTrak2018 Blood Establishment Computer Software and Accessories |
LifeTrak® 2018 is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
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BK180200/0 | Mediware Information Systems, Inc. 11711 West 79th Lenexa, KS 66214 |
7/3/2018 |
DonorScreen-HLA® Class I and Class II Test, HLA |
DonorScreen-HLA® Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the STRATEC BIOMEDICAL AG® GEMINI instrument. DonorScreen-HLA® Class I and Class II assay ELISA is designed to detect anit-HLA class I and class II antibodies in human serum or plasma of blood donors. | BK180181/0 | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
6/14/2018 |
RD1 System Peripheral blood processing device for wound management |
The RD1 System is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot get from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the whole blood clot gel produced by the RD1 System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers, and mechanically or surgically-debrided wounds. | BK170095/0 | RedDress Ltd Shkedim Street 11, Pardes Hanna, Zip 3701142 Israel |
6/14/2018 |
Biowy Freezing Bag Frozen Donor Tissue Storage Container |
The Biowy Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196 Celsius) and subsequent thawing (at +37 Celsius) of hematopoietic progenitor cells. | BK170150/0 | Biowy Corporation 27031 Vista Terrace Lake Forest, California 92630 |
5/11/2018 |
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System Platelet And Plasma Separator for Bone Graft Handling |
The Arthrex Angel concentrated Platelet Rich Plasma (cPRP) System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of whole blood or a small mixture of blood and bone marrow. The platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site. The Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (cPRP) System is designed for the preparation of autologous serum from anticoagulated peripheral blood or platelet poor plasma that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics. | BK170144/0 | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 |
5/10/2018 |
TANGO Infinity Software Version 1.5 Automated Blood Grouping and Antibody Test Systems |
The TANGO infinity automated blood grouping and antibody test system is an automated instrument intended for the in vitro serological analysis of human blood specimens. In the USA, TANGO is “RX only”and operates with TANGO Infinity Software Version 1.5. It generates results from individual images that must be verified by visual inspection by a qualified person called a validator. In rare cases, where the software is unable to decide, manual editing may be necessary. TANGO Infinity utilizes Erytpe S agglutination metholodology for ABO (forward and reverse blood grouping), Rh(D), Rh Phenotype and Kell blood grouping. TANGO infinity utilizes Solidscreen II solidphase methodology for weak D and partial D testing, antibody screening and identification of red cell alloantibodies, auto control and direct antiglobulin testing. The TANGO infinity uses reagents and microwell strips approved for the TANGO infinity. Operators of TANGO infinity must be trained by authorized personnel and must be familiar with the content of this TANGO infinity User Manual. This TANGO infinity User Manual is designed to serve as a reference manual for operations and troubleshooting, to assist writing institutional SOPs and to assist in training. |
BK180175/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, 63303 Dreieich, Germany |
5/1/2018 |
IH-Com V5.0 Automated Blood Grouping and Antibody Test Systems |
IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for blood samples that are tested on the IH-1000 with IH-System reagents or the TANGO infinity®; with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with:
IH-Com V5.0 should only be operated by trained personnel and is not intended for use in a direct patient environment. In the USA IH-Com V5.0 is “Rx only”. |
BK180174/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, 63303 Dreieich, Germany |
5/1/2018 |
PCS 300 Plasma Collection System (Software Version 1.2.0) Automated Blood Cell Separators |
The PCS 300 Plasma Collection System is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the PCS 300 system include source plasma and plasma for transfusion. | BK180185/0 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
3/27/2018 |
Neg Control Quality Control Kits for Blood Banking Reagents |
Neg Control is used as a negative control in conjunction with DIAGAST monoclonal Anti-D reagents (210524-210525-210526). | BK160084/0 | DIAGAST Parc Eurasanté 251, Avenue Eugéne BP 9, LOOS Cedex, France 59374 |
2/2/2018 |
BacT/ALERT® BPA Culture Bottle Bacterial Detection Systems for Platelet Transfusion Products |
BacT/ALERT® BPA culture bottles are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi). BacT/ALERT® BPN culture bottle are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic and facultative anaerobic microorganisms (bacteria). BacT/ALERT Microbial Detection Systems and culture bottles may be used for quality control testing of platelets and as a secondary safety measure test. Bacterial tests are labeled as safety measure when they show benefit for detection of bacterial contamination not revealed by previous bacterial testing. The laboratory should follow its own quality control procedures for these uses. |
BK170142/0 | BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
2/1/2018 |
EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) Fibrin Sealant Preparation Device |
The EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) is intended to be used with the EVICEL™ Application Device for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant (Human) onto the surface. | BK170138/0 | ETHICON Inc. Route 22 West Somerville, New Jersey 08876 |
1/26/2018 |
UltraCW®II Automatic Cell Washing System Automated cell-washing centrifuge for immune-hematology |
The UltraCW®II Automatic Cell Washing System is intended to be used for the washing portion of routine blood bank and laboratory procedures calling for washed red blood cells such as antiglobulin testing, ABO compatibility, Rh, cross matching and anti-body screening. The UltraCW®II Automatic Cell Washing System should be operated by a trained individual such as a clinical laboratory technologist or similar education as determining whether desired results have been achieved is subjective and is dependent upon user preparation of blood sample, and parameter selection/adjustment. |
BK170141/0 | Helmer Inc. 14400 Bergen Boulevard Nobelsville, IN 46060 |
1/22/2018 |
Procleix Xpress® System (Software v3.0) Automated blood grouping and antibody test system |
The Procleix Xpress® System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress® System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix® systems. The Procleix Xpress® System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress® System can be used to dispense human plasma or serum aliquots into an archive plate. | BK170162/0 | Grifols Diagnostic Solutions Inc. 4560 Horton Street Emeryville, CA 94608 |
1/18/2018 |
Cyclone Blood & Bone Marrow Concentration (BBMC) System Platelet And Plasma Separator For Bone Graft Handling |
The Cyclone Blood BBMC System is designed to be used intraoperatively at the point of care for the safe and rapid preparation of a platelet concentrate (platelet rich plasma or PRP) from a small sample of a mixture of peripheral blood and bone marrow. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improved handling characteristics. | BK170108/0 | Alliance Partners LLC 14206 Northbrook Drive San Antonio, TX 78232 |
1/2/2018 |