2022 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 |
|---|---|---|---|---|
| Sterile Tube Welder (Model: STW6810-RFID) Transfer set |
The Sterile Tube Welder (STW6810-RFID) 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. The Sterile Tube Welder is not to be used with tubing connected to a person. This device is for use by trained individuals in such settings as blood bank laboratories and hospitals. |
BK220673/0 | Wuhan BMS Medicaltech Co., Ltd Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza Shuixi Road, Huangpu District Guangzhou China |
10/24/2022 |
| Procleix® WNV/Babesia Quality Control Assayed quality control material for clinical microbiology assays |
Procleix® WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System. This product is intended to be used solely with the Procleix Babesia Assay or Procleix WNV Assay, licensed donor screening assays performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device. | BK220746/0 | Grifols Diagnostic Solutions Inc. 4560 Horton Street Emeryville, CA 94608 |
10/14/2022 |
| Blood Typing Manager Blood Establishment Computer Software and Accessories |
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System.
|
BK220744/0 | Diagnostic Grifols, S. A. Elvira Estapé Passeig Fluvial, 24 Parets del Valles, Barcelona 08150 Spain |
10/04/2022 |
| MATCH IT!® Antibody Test, Qualitative, for HLA, Non-Diagnostic |
MATCH IT!® Antibody software v1.5 is an optional accessory to the following LIFECODES antibody detection kits for use with Luminex: LIFECODES® Class I ID PN 628200 IFU LC807IVD LIFECODES® Class II ID v2 PN 628223 IFU LC807IVD LlFECODES® Lifescreen Deluxe PN 628215 IFU LC1003IVD LIFECODES® LSA Class I PN 265100IVD lFU LC1683IVD LIFECODES® LSA Class Il PN 265200IVD IFU LC1683IVD LIFECODES® LifeScreen XP PN 628220 IFU LC1698IVD Default settings for all assays are aligned with the IFU and the performance characteristics of the assay. Any other methods of assignment would need to be validated by lab personal prior to use. The software is intended for In vitro diagnostic use. |
BK220762/0 | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
09/29/2022 |
| LIFECODES LifeScreen XP | LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect lgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient matching in transfusion or transplantation. A Luminex Instrument is required to run the LIFECODES LifeScreen XP assay. The MATCH IT!® Antibody Software is an accessory intended as an aid in the analysis of LIFECODES LifeScreen XP assay. Laboratory professionals are the intended user of the device. | BK220763/0 | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
09/29/2022 |
| Arthrex Autologous Conditioned Plasma (ACP) Max™ PRP System Platelet and Plasma Separator for Bone Graft Handling |
The Arthrex Autologous Conditioned Plasma (ACP) Max™ PRP system is indicated to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate platelet rich plasma (PRP) from a small sample of peripheral blood or 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 improving handling characteristics. | BK210655/0 | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 |
09/22/2022 |
| Procleix® HIV-1/HCV/HBV Quality Control Assayed quality control material for clinical microbiology assays |
Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay, a licensed donor screening assay performed on the Procleix Panther System. This product is intended to be used solely with the Procleix Ultrio Elite Assay performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device. | BK220736/0 | Grifols Diagnostic Solutions Inc. 4560 Horton Street Emeryville, CA 94608 |
09/16/2022 |
| IMUGARD® WB PLT Platelet Pooling Set Empty container for the collection and processing of blood and blood components |
IMUGARD® WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool, and store whole-blood-derived platelets. Leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a "safety measure." |
BK210658/0 | Terumo BCT, Inc. 10810 West Collins Avenue Lakewood, CO 80215 |
08/26/2022 |
| st’rim™, macro st’rim™, mini st’rim™, and nano st’rim™ Suction lipoplasty system |
The st’rim™, macro st’rim™, mini st’rim™, and nano st’rim™ fat tissue and injection cannula sets are intended for use in aesthetic body contouring. | BK220750/0 | THIEBAUD SAS 9 Rue Geoffroy-Saint-Hilaire 75005 Paris, France |
08/26/2022 |
| Galileo NEO® Automated Blood Grouping and Antibody Test System |
The Galileo NEO is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo NEO automates test processing, result interpretation and data management functions. The Galileo 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 and antigen screening. The Galileo NEO is for in vitro diagnostic use. |
BK220670/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
07/26/2022 |
| NEO Iris® Automated Blood Grouping and Antibody Test System |
The NEO Iris is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. The NEO Iris 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 and antigen screening. The NEO Iris is for in vitro diagnostic use. |
BK220669/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
07/26/2022 |
| Genesis RapidWeld II STW, model GRW-430-02 Transfer set |
The Genesis RapidWeld II, model GRW-430-02, is used to make a sterile connection/weld between two segments of PVC tubing used in blood/blood component processing applications. | BK210584/0 | GenesisBPS, LLC 465 State Route 17 Ramsey, NJ 07446 |
07/15/2022 |
| RegenKit®-Wound Gel-2 Peripheral blood processing device for wound management |
RegenKit-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel 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. | BK210661/0 | RegenLab SA 37743, 175th Avenue Avon, Minnesota 56310 |
07/08/2022 |
| ORTHO Optix™ Reader Automated Blood Grouping and Antibody Test System |
The ORTHO Optix™ Reader is a system designed to automate reaction grading, results interpretation and data management when performing in vitro immunohematology testing of human blood utilizing ID-MTS Gel card technology. The ORTHO Optix™ Reader can be used as a standalone instrument or interfaced to the customer’s Laboratory Information System (LIS). | BK220724/0 | Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202 Raritan, NJ 08869 |
06/24/2022 |
| ORTHOTM Daily QC Simulated Whole Blood Quality Control Kit Quality control kit for blood banking reagents |
The ORTHO™ Daily QC Simulated Whole Blood Quality Control Kit (ORTHO™ Daily QC Kit) is intended for use as qualitative controls of ABO and Rh phenotyping and antibody screening using the ID-Micro Typing System™, ORTHO™ Workstation with or without ORTHO Optix™ Reader, ORTHO VISION® Analyzer, and ORTHO VISION® Max Analyzer. The ORTHO™ Daily QC kit for in vitro diagnostic use only. The product is for use by professional users trained in blood typing techniques |
BK210653/0 | Millipore (UK) Ltd. 3 Fleming Road, Kirkton Campus Livingston EH54 7BN United Kingdom |
06/07/2022 |
| Sysmex XN-10 Automated Hematology Analyzer Automated differential cell counter |
The Sysmex XN-10 Automated Hematology Analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-10 classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, NRBC%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, IPF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF# parameters in cerebrospinal fluids (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood, should be collected in K2 or K3EDTA anticoagulant and, serous and synovial fluids in K2EDTA to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. The XN-10 Blood Bank mode is intended for use in blood processing centers for QC release testing of post-processed components. The Blood Bank mode enumerates RBC, HGB and HCT parameters for red blood cell components with anticoagulants (CPD, CP2D, ACD-A, CPDA-1) as well as PLT for platelet components with anticoagulants (CPD, ACD-A). The Blood Bank mode also performs residual WBC counts on leukoreduced red blood cell and platelet components. |
BK210631/0 | Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
05/23/2022 |
| Precise Cell Concentration System Platelet and Plasma Separator for Bone Graft Handling |
The Precise Cell 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. | BK200540/0 | Arteriocyte Medical Systems, Inc. 45 South Street, Suite 3 Hopkinton, MA 01748 |
03/17/2022 |
| MicroAire LipoFilter® System Suction lipoplasty system |
The MicroAire LipoFilter System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. | BK220674/0 | MicroAire Surgical Instruments, LLC. 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 |
03/16/2022 |
| Rika Plasma Donation System Rika Plasma Separation Set Rika Plasma Bottle Automated blood cell separator |
The Rika Plasma Donation System is an automated blood cell separator device and single-use sterile disposable set intended for use in collecting source plasma with or without saline compensation. | BK210635/0 | Terumo BCT, Inc 10811 West Collins Avenue Lakewood, CO 80215 |
03/07/2022 |
| IH-500 Automated blood grouping and antibody test system |
The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, and provides reaction grading / interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control, direct antiglobulin testing and antibody titration testing. In the USA, IH-500 is “Rx only”. The IH-500 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-500 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. Use of IH-500 is only permitted with gel cards and reagents from the IH-System as authorized by Bio-Rad. The use of any material not specified in the U.S. User Manual (e.g. non-authorized substances) is forbidden. |
BK210625/0 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories Inc. 6565 185th Ave NE Redmond, WA 98052 |
02/28/2022 |
| Platelet-Rich Plasma (PRP) Procedure Pack Platelet And Plasma Separator for Bone Graft Handling |
The Platelet-Rich Plasma (PRP) Procedure Pack is indicated 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 for improving handling characteristics. | BK210591/0 | Terumo BCT, Inc 10810 West Collins Ave Lakewood, Colorado 80215 |
02/11/2022 |
| Royal MAXX PRP Concentration System Platelet and Plasma Separator for Bone Graft Handling |
The Royal MAXX PRP Concentration System is designed to be used at the patient's point of care for the safe and rapid preparation of a platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate that is mixed with autograft and or allograft bone prior to application to a bony defect for improving handling characteristics. | BK210632/0 | Royal Biologics, Inc. 401 Hackensack Avenue, Suite 604 Hackensack, NJ 07601 |
02/11/2022 |
| BD® Stem Cell Enumeration Kit Automated differential cell counter |
The BD® Stem Cell Enumeration Kit is intended for enumeration of viable dual-positive CD45+/CD34+ hematopoietic stem cell populations to determine absolute counts (cells/μL) of viable CD34+ and the percentages of viable CD45+/CD34+ hematopoietic stem cells (%CD34). The following cellular-based products (specimens) can be analyzed with this kit: • Normal and mobilized peripheral blood • Fresh and thawed leukapheresis products • Fresh and thawed bone marrow • Fresh and thawed cord blood The kit is intended for in vitro diagnostic (IVD) use on any of the following flow cytometer systems: • BD FACSLyric ™ flow cytometer using BD FACSuite ™ Clinical application • BD FACSCanto ™ II flow cytometer using BD FACSCanto ™ clinical software • BD FACSCalibur ™ flow cytometer using BD CellQuest ™ or BD CellQuest ™ Pro software |
BK210652/0 | Becton, Dickinson & Company 2350 Qume Drive San Jose, CA 95131 |
01/27/2022 |
| LOGIC 4.0.8 Blood Establishment Computer Software and Accessories |
The intended use of LOGIC is to organize and control the transport of units between facilities such as collection sites, warehouses and fractionators. LOGIC also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems. | BK210650/0 | CSL Plasma 1001 Corridor Park Boulevard Knoxville, TN 37934 |
01/25/2022 |
| BD Vacutainer® ACD A Blood Collection Tube BD Vacutainer® ACD B Blood Collection Tube Blood Specimen Collection Devices |
BD Vacutainer® ACD A and B Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens for the purpose of in vitro diagnostic testing. BD Vacutainer® ACD A and B Blood Collection Tubes may be used for testing in immunohematology, such as ABO grouping and Rh typing. The performance characteristics of these tubes have not been established for immunohematology testing in general; therefore, users must validate the use of these tubes for their specific assay- instrument/reagent system combinations and specimen storage conditions. |
BK210649/0 | Becton, Dickinson & Company 1 Becton Drive Franklin Lakes, NJ 07417 |
01/21/2022 |