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 |
|---|---|---|---|---|
| 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 |