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.
| 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 -(b)(4)----------------- ------------------------------ --------------------------------- |
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 |