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  1. Development & Approval Process (CBER)

2021 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.

2021 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
RD2 Ver.02 System
Peripheral Blood Processing Device for Wound Management
The RD2 Ver.02 System is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the RD2 Ver.02 System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds. BK210570/0 RedDress Ltd
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia, PA 19103
06/22/2021
Sysmex XN-10 Automated Hematology Analyzer
Counter, Differential Cell
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%/#, BO%/#, 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 :KJEDTA anticoagulant and, serous and synovial fluids in 1<2EDTA 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).
BK210559/0 Sysmex America Inc.
577 Aptakisic Road
Lincolnshire, IL 60069-4325
05/27/2021
ORTHO VISION® Max Analyzer
Automated blood grouping and antibody test system
ORTHO VISION Max Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing ID-MTS gel card technology. ORTHO VISION Max Analyzer automates test processing functions including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation, and data management requirements using cards and digital image processing. ORTHO VISION Max Analyzer can be used as a standalone instrument or interfaced to the customer’s Laboratory Information System (LIS). BK210564/0 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
Raritan, NJ 08869
05/13/2021
ORTHO VISION® Analyzer
Automated blood grouping and antibody test system
ORTHO VISION Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing ID-MTS gel card technology. ORTHO VISION Analyzer automates test processing functions including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation, and data management requirements using cards and digital image processing. ORTHO VISION Analyzer can be used as a standalone instrument or interfaced to the customer’s Laboratory Information System (LIS). BK210557/0 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
Raritan, NJ 08869
05/13/2021
Sunquest Transfusion Manager™ Version 3.0
Blood establishment computer software and accessories
Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services. Transfusion Manager helps users manage the following transfusion service activities:
  • Positively identify transfusion recipients.
  • Match blood products to recipients.
  • Record recipient pertinent transfusion information.
  • Record recipient transfusion reactions and caregiver comments.
BK210556/0 Sunquest Information Systems, Inc.
3300 Sunrise Drive
Tucson, AZ 85718
04/16/2021
Royal Maxx Autologous PRP Concentration System
Platelet and Plasma Separator for Bone Graft Handling
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 for mixing with autograft and/or allograft bone to improve handling characteristics. BK210563/0 Royal Biologics, Inc
401 Hackensack Avenue, #604
Hackensack, NJ 07601
04/16/2021
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.
BK210560/0 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
04/12/2021
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.
BK210562/0 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
04/12/2021
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). BK200549/0 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
Raritan, NJ 08869
03/10/2021
Ranfac Autologous Platelet Seperator
Platelet and Plasma Separator for Bone Graft Handling
The Ranfac Autologous Platelet Separator 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 for mixing with autograft and/or allograft bone to improve handling characteristics. BK200543/0 Ranfac Corporation
30 Doherty Ave
Avon, MA 02322
02/24/2021
Capture-CMV®
Test, Donor, CMV
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 blood and plasma donors for serological evidence of previous infection by CMV using the NEO Iris® and Galileo NEO®.

This assay is not intended for diagnostic use.
BK200542/0 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
02/08/2021
ASI Automated RPR test for Syphilis for use on the ASI Evolution
Antigens, Nontreponemal, All
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis for use on the ASI Evolution, 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.

The ASI Evolution is intended to be used as a fully automated analyzer to objectively interpret the results of the ASI Automated RPR Test for Syphilis. The ASI Evolution is designed to provide standardized test interpretation and to provide for storage, retrieval, and transmittal of the test results.

The ASI Automated RPR Test for Syphilis for use on the ASI Evolution is for professional use only. The test is intended to be used for blood donor screening and for cadaveric (non-heart beating) donor specimens for tissue donation. This test is not intended for diagnostic use.
BK200539/0 Arlington Scientific, Inc.
1840 North Technology Drive
Springville, UT 84663
02/02/2021
Reapplix 3C Patch System
Automated blood cell separator
The 3C Patch System is intended to be used at point-of-care for 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.
BK200471/0 Reapplix A/S
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01/13/2021
IH-1000
Automated blood grouping and antibody test system
The IH-1000 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. In the USA, IH-1000 is “Rx only”. The IH-1000 automates pipetting of samples and reagents, incubation and centrifugation, provides reaction grading / interpretation based on results from gel card images. BK200548/0 Bio-Rad Medical Diagnostics GmbH
Bio-Rad Laboratories Inc.
6565 185th Avenue NE
Redmond, WA 98052
01/12/2021
LABScreen Multi
Test, Qualitative, for HLA, Non-Diagnostic
LABScreenMulti is intended for the detection of antibodies to human leukocyte antigens or detection of antibodies to human neutrophil antigens. BK200546/0 One Lambda, Inc.
22801 Roscoe Boulevard
West Hills, CA 91304
01/06/2021
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