2017 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.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| Treponema pallidum nontreponemal test reagents | The ASI Automated RPR (rapid plasma reagin) Test for syphilis is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis for use on the ASI Evolution analyzer. The ASI RPR Test for Syphilis is for professional use only. The test is intended for use in screening blood donors. | BK170114/0 |
Arlington Scientific, Inc. |
12/28/2017 |
|
Quality Control Kits for Blood Banking Reagents |
The IH-Basic QC is intended for daily quality control of blood bank reagents including Blood Grouping Reagents for ABO/Rh, Rh Phenotyping, K, Reagent Red Blood Cells and reagents for antibody detection. The IH-Basic QC is "Rx Only". For use with IH-Card Technique using the IH-1000 Analyzer. |
BK170075/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, GM 63303 |
12/20/2017 |
|
Refractor for Donor testing |
The TS Meter-DSP is for the qualitative measurement of total protein in human serum/plasma. The device is intended for use in plasma collection centers and is not for diagnostic purposes. | BK 170128/0 | Reichert, Inc. 3362 Walden Avenue, Suite 100 Depew, NY 14043 |
12/19/2017 |
| Manual blood grouping and antibody systems |
The IH-Centrifuge L is intended for cetrifugation of IH-System gel cards and/or test tubes for in vitro immunohematology testing of human blood. In the USA, IH-Centrifuge L is “Rx only.” The IH-Centrifuge L may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-Centrifuge L is only permitted in conjuction with the corresponding software or in a configuration authorized by Bio-Rad. The use of any material not specified in the User Manual (e.g. non-authorized substances) is under users responsibility. |
BK170065/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, GM 63303 | 12/18/2017 |
| Manual blood grouping and antibody systems |
The IH-Incubator L is intended for cetrifugation of IH-System gel cards and/or test tubes for in vitro immunohematology testing of human blood. In the USA, IH-Incubator L is “Rx only.” The IH-Incubator L may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-Incubator L is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. |
BK170066/0 |
Bio-Rad Medical Diagnostics GmbH |
12/18/2017 |
| Quality Control Kits for Blood Banking Reagents |
The IH-Internal QC is intended for blood grouping controls including antisera for ABO/Rh, Rh Phenotyping, K, Reagent Red Blood Cells and reagents for antibody detection and identification. The IH-Internal QC is designed to be used with IH-Cards only with the manual method. The IH-Internal QC is “Rx only.” |
BK170064/0 |
Bio-Rad Medical Diagnostics GmbH |
12/18/2017 |
| sparse sample pk profile and dosing software |
The myPKFiT for ADVATE software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. myPKFiT for ADVATE can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body weight of 45kg or greater, using that patient’s age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient. A minimum of two sparse sampling points are required at the recommended 3-4 hours (±30 minutes) and at 24-32 hours (±1 hour) post-infusion. HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient’s needs and treatment plan. The medical device output may be used to guide decisions on appropriate ADVATE dose and infusion intervals to maintain FVIII activity levels at or above a user specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with FDA approved dosing recommendations provided in the ADVATE Prescribing Information (PI). myPKFiT for ADVATE should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADVATE, as per the ADVATE PI. myPKFiT for ADVATE is not indicated for the treatment of von Willebrand disease. myPKFiT for ADVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products. |
BK170028/0 |
Baxalta US Inc. |
12/14/2017 |
|
VITROS Immunodiagnostic Products HIV Combo Reagent Pack VITROS Immunodiagnostic Products HIV Combo Calibrator HIV-1/2 Ag/Ab Test |
VITROS Immunodiagnostic Products HIV Combo Reagent Pack is for the simultaneous qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) types 1, including group M and O, and/or 2 (anti-HIV-1 and anti-HIV-2) and HIV p24 antigen in human serum and plasma (heparin and EDTA) in adults, pregnant women, adolescents and children (as young as 2 years of age), using the VITROS 3600 Immunodiagnostic System. The VITROS HIV Combo Calibrator is for use in the calibration of the VITROS 3600 Immunodiagnostic System. |
BP160122/0 | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY, 14626, US |
12/13/2017 |
| Blood Bank Supplies | To aid in the extraction of a biological fluid sample from a segmented piece of tubing. Single use only. For in vitro diagnostic use only. | BK170102/0 |
ITL Corporation Pty, Ltd 41-45 Tennant Street, Canberra ACT 2609, AS |
11/28/2017 |
|
Fibrinet®Platelet System Platelet And Plasma Separator For Bone Graft Handling |
The Cascade Medical FIBRINET® System 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. |
BK170096/0 |
Cascade Medical Enterprises, LLC 20 Greenup Court, Wayne, NJ, 07470, US |
11/21/2017 |
| Blood Bank Supplies |
The MacoPress Smart (MPS) and DMS Plus consist of two parts: the MacoPress Smart device and the DMS Plus Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS Plus software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed. |
BK170085/0 |
MacoProductions S.A.S.
|
11/9/2017 |
|
Erytra® Automated Blood Grouping and Antibody Test Systems |
The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel® 8 card 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), the Erytra® automates test processing functions and data management requirements using DG Gel® 8 cards and digital image processing. |
BK170130/0 |
Diagnostic Grifols, S. A. |
11/1/2017 |
| Aurora Enterprise Blood Establishment Computer Software and Accessories |
Aurora Enterprise is a computer software product for use within Blood Establishments and Clinical Diagnostic Laboratories which enables communication between Laboratory Information Systems and Laboratory Instrumentation. The software product is designed to capture and collate data provided by laboratory instrumentation, where the instrumentation is capable of performing its own data processing, having qualified the data and converted the raw values into interpreted results. The software collects data of assays from instruments, which allow operators to track patient samples and link them to the appropriate test results. The software collates the results of testing, and formats output files that can be sent to a Laboratory Information System (LIS). Typical tests would include those that are used to screen blood donations (whole blood or plasma) as a pre-requisite to transfusion such as viral markers tested by NAT/PCRand Immunoassay. The software has the capability to send worklists to instruments from orders it receives from an LIS, or manually entered, but takes no control over any instrument operation. | BK160071/0 | STRATEC Biomedical UK Limited Third Ave, Centrum 100, Straffordshire, UK |
10/30/2017 |
| AlbaQ-Chek Simulated Whole Blood Controls Quality Control Kits for Blood Banking Reagents |
AlbaQ-Check is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. | BK170086/0 | Alba Bioscience Limited 21 Ellen's Glen Rd, Edinburgh EH17 7QT Scotland |
10/20/2017 |
| ORTHO CONNECT Automated Blood Grouping and Antibody Test System |
ORTHO CONNECTTM Software is designed to collect data from the Ortho Clinical Diagnostics ORTHO VISIONTM Analyzer and its proprietary immunology/hematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation. | BK160124/0 | STRATEC Biomedical UK Limited 98 Main St. Suite 205 Southington, CT, 06489 |
10/17/2017 |
| AMICUS Separator System Automated Blood Cell Separators |
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE), and to collect blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. | BK170099/0 | Fresenius Kabi USA LLC. Three Corporate Drive, Lake Zurich, IL, 60047 |
10/10/2017 |
| Charter Medical Cell Therapy Fluid Transfer Set Transfer Sets |
For the sterile transfer of bone marrow derived mononuclear cells from one container to another. The fluid transfer sets are provided sterile (fluid path) by gamma irradiation and are intended for single use. | BK170004/0 | Charter Medical, Ltd. 3948-A Westpoint Blvd. Winston-Salem, NC, 27103 |
10/6/2017 |
| One Lambda LABTypeTM XR and CWD DNA Typing Tests Qualitative Test for HLA, Non-diagnostic |
For use to determine HLA A, B, C and DRB1 locus typing to aid in transfusion and transplantation donor recipient matching. | BK170053/0 | One Lambda, Inc. 21001 Kittridge St. Canoga Park, CA, 91303 |
10/5/2017 |
| TSCD®-II Sterile Tubing Welder with or without Trucise Total System™ Transfer Sets |
The Terumo Sterile Connecting Device (TSCD®-II) is used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components. These welds may consist of dry-to-dry, wet-to-dry or wet-to-wet connections. The resulting sterile component may be used in blood collection, blood component processing or transfusion applications. | BK170098/0 | Terumo BCT, Inc 10811 W. Collins Ave., Lakewood, CO, 80215 |
9/29/2017 |
| DXT Data Management System v3.0 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 procedures 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. | BK170072/0 | Fresenius Kabi AG Three Corporate Dr, Lake Zurich, IL, 60047 |
9/26/2017 |
| IH-Com V5.0 Automated Blood Grouping and Antibody |
IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for the blood samples that are tested on the IH-1000 with IH-System reagents. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with a standalone IH-1000, with multiple IH-1000s, or connected to a Laboratory Information System. The user can access selected functions of IH-Com V5.0 from remote locations using IH-Web 2.0. 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-ComV5.0 is “Rx only”. | BK170071/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, GM |
9/26/2017 |
|
Aurora Xi Plasmapheresis System/Aurora Xi/Aurora Xi system/Aurora Xi Software Version 1.1 |
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. | BK170057/0 | Fresenius Kabi AG Three Corporate Dr, Lake Zurich, IL, 60047 |
8/25/2017 |
| MacoMix HM20 and Hemolog 6 Blood Mixing and Weighing Devices |
The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood 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 preset target volume has been reached. | BK160095/0 | MacoProductions S.A.S. 200 chaussee Fernand Forest, Tourcoing, 59200, FR |
8/11/2017 |
| Haemonetics PCS 300 Plasma Collection System 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. | BK170045/0 | Haemonetics Corporation 400 Wood Road, Braintree, MA 02184 |
7/25/2017 |
| Duploject,Duo Set and Duo Set A Piston Syringe |
Duploject: For the preparation and application of Tisseel Fibrin Sealant kit. Duo Set: For the application of Tisseel Fibrin Sealant. Duo Set A: For the application of Artiss Fibrin Sealant. Prescription | BK170033/0 | Baxter Healthcare Corporation 32650 North Wilson Rd, Round Lake, IL 60073 |
07/24/2017 |
| Bone Marrow Collection Stand Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters Bone Marrow Collection Kit and Accessories |
The Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters and Bone Marrow Collection Stand are used for the collection and filtration of aspirated bone marrow for bone marrow transplantation. | BK170030/0 | Fresenius Kabi AG Three Corporate Drive, Lake Zurich, IL 60047 |
07/24/2017 |
| Galileo Neo® Automated Blood Grouping and Antibody Test Systems |
The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate- based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can be subjected to confirmation using a licensed method. The NEO is intended for use only with the reagents described in Attachment 1 for Galileo Neo Operator Manual. | BK170067/0 | Immucor, Inc. 3130 Gateway Drive, P.O.Box 5625 Norcross, GA 30091 |
7/19/2017 |
| Trima Accel (R) 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. | BK170059/0 | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 |
7/7/2017 |
| Blood Product Administration Module, Version 2-2017 Blood Establishment Computer Software and Accessories |
The Blood Product Administration Module is a software module intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion. The Module is based on a modular design allowing it to be used with a host electronic health record system. The Module can, through use of barcode technology, assist healthcare professionals in verifying patient identity at the bedside. The Module receives and manages information from orders placed from host system and blood product information from an external blood bank system. The Module incorporates system-controlled logic that can require a positive match of the patient, the blood product to be administered, and information received from the external blood bank system. The Module can also check a blood product's documented expiration date for appropriateness. Blood administration information entered in the Module is transmitted to the host system for storage. | BK170032/0 | Epic Systems Corporation 1979 Milky Way, Verona, WI, 53593 |
06/28/2017 |
| Elecsys HIV combi PT HIV Detection Test |
The Elecsys HIV combi PT is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than 2 years of age and in pregnant women. The Elecsys® HIV combi PT Immunoassay is not intended for the screening of blood or plasma donors. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 602 immunoassay analyzer. | BP160050/0 | Roche Diagnostics 9115 Hague Road, Indianpolis, IN, 46250 |
06/21/2017 |
| AlbaQ-Chek ® Simulated Whole Blood Controls, Model Z498 Quality Control Kits for Blood Banking Reagents |
Intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. | BK170013/0 | Alba Bioscience Limited 21 Ellen's Glen Rd, Edinburgh, Midlothian, EH17 7QT United Kingdom |
05/9/2017 |
| IH-1000 (Model# 001100) Automated Blood Grouping and Antibody Test Systems |
The IH-1000 is designed for Blood Grouping Determination using the IH-Cards, utilizing hemagglutination and gel filtration as principle of operation. The instrument is intended to perform the detection of ABO, RhD (including weak D and partial D testing), Rh and Kell blood grouping for patient and donor samples as well as detection and identification of clinical relevant antibodies, cross matching and Direct Antiglobulin testing using the IH System reagents. | BK170019/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, 63303, GM |
05/5/2017 |
| 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. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with a standalone IH-1000, with multiple IH-1000s, or connected to a Laboratory Information System. 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”. |
BK170021/0 | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, 63303, GM |
05/5/2017 |
| Procleix® NAT Manager® v1.2 Software Instrumentation for Clinical Multiplex Text Systems |
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports. Procleix NAT Manager Software is intended to be used by Blood Establishment personnel who are trained in its operation and familiar with the associated assays and instruments. | BK160125/0 | STRATEC Biomedical UK Limited Third Ave, Centrum 100, Straffordshire, UK |
4/25/2017 |
| cobas Synergy Software (Version 1.0) /Data acquisition software | cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas? 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments. | BK160113/0 | STRATEC Biomedical UK Limited 98 Main Street, Southington, CT, 06489 |
4/19/2017 |
| AMICUS Separator System Automated Blood Cell Separators |
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). | BK160112/0 | Fresenius Kabi USA LLC. Three Corporate Drive, Lake Zurich, IL, 60047 |
4/7/2017 |
| Platelet PGD® Test System Microbial Growth Monitor |
The Platelet PGD Test is a rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in
|
BK160087/0 | Verax Biomedical Incorporated 148 Bartlett Street, Marlborough, MA, 01752 |
4/6/2017 |
| 3C Patch System Peripheral blood processing device for wound management |
The 3C Patch System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch 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. | BK170002/0 | Reapplix Aps Blokken 45, 3460 BirkerØd Denmark |
4/3/2017 |
| Alyx Component Collection System Automated Blood Cell Separators |
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components. | BK170001/0 | Fenwal Inc Three Corporate Dr, Lake Zurich, IL, 60047 |
04/3/2017 |
| MQC-CAT Quality Control Kits for Blood Banking Reagents |
MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techniques and for the quality control of certain antigen typing reagents including C, c, E, and e antigents. | BK160081/0 | Hemo bioscience, Inc. 633 Davis Drive, Morrisville, NC, 27560 |
03/30/2017 |
| HLA Fusion™ Software Version 4.0 Qualitative Test for HLA, Non-diagnostic |
HLA Fusion™ Software is an accessory for the evaluation of test results from One Lambda, Inc. products for molecular typing and antibody detection. | BK160017/0 | One Lambda, Inc. 21001 Kittridge St., Canoga Park, CA, 91303 |
3/8/2017 |
| LABType™ XR and CWD DNA Typing Test Qualitative Test for HLA, Non-diagnostic |
To determine HLA A, B, DRB1 locus typing to aid in transfusion and transplantation donor recipient matching. | BK160018/0 | One Lambda, Inc. 21001 Kittridge St., Canoga Park, CA, 91303 |
3/6/2017 |
| MQC Quality Control Kits for Blood Banking Reagents |
MQC is intended for the quality control of routine blood bank reagents and for the quality control of certain antigen typing reagents including C, c, E,e, Jka, Jkb,K, Fya and Fyb antigents. | BK160079/0 | Hemo bioscience 633 Davis Drive, Morrisville, NC, 27560 |
02/27/2017 |
| cobas® HIV-1 HIV Detection Test |
Cobas HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1 infected individuals using the automated cobas 6800/8800 specimen processing, amplification and detection systems. This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment. The cobas HIV-1 test is not intended for use as a screening test for the presence of HIV-1 infection. | BP150262/6 | Roche Molecular Systems, Inc. 4300 Hacienda Drive, Pleasanton, CA, 94588 |
02/10/2017 |