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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
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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