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 |
|---|---|---|---|---|
| Stem-Kit Reagents, stemCXP System Automated differential cell counter |
Stem-Kit Reagents consist of a two-color fluorescent (FITC, PE) murine monoclonal antibody reagent, a two-color murine fluorescent (FITC, PE) isoclonic control, an absolute count reagent, a cell viability reagent, and a lysing reagent. It is intended “For In Vitro Diagnostic Use” for the simultaneous identification and enumeration of CD45+ and dual-positive CD45+ CD34+ cell population percentages and absolute counts in biological specimens by flow cytometry. Biological specimens include fresh normal or mobilized peripheral whole blood, and fresh or thawed apheresis products, cord blood and bone marrow. Cell population measurements may be obtained using either an automated method or a manual method for gating and analysis. Refer to this Stem-Kit Reagents package insert for complete instructions if using the manual method. Refer to the stemCXP System Guide provided with the stemCXP for complete instructions if using the automated method. The stemCXP SYSTEM, comprised of stemCXP Software for FC 500 flow cytometry systems with CXP software, Stem-Kit Reagents, quality control and standardization reagents, provides automated analysis of cell populations in fresh peripheral or mobilized peripheral whole blood, fresh bone marrow, and fresh or thawed apheresis products and cord blood. The stemCXP SYSTEM is intended for In Vitro Diagnostic Use to simultaneously identify and enumerate CD45+ and CD45+/CD34+ dual-positive cell populations. |
BK210639/0 | Beckman Coulter Inc. 11800 SW 147 Avenue M/S 31-K21 Miami, FL 33196-2500 |
12/15/2021 |
| MATCH IT! ® Antibody software v1.4 Test, Qualitative, for HLA, Non-Diagnostic |
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 LIFECODES® Lifescreen Deluxe PN 628215 IFU LC1003IVD LIFECODES® LSA Class I PN 265100IVD IFU LC1683IVD LIFECODES® LSA Class II PN 265200IVD IFU LC1683IVD 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. |
BK210572/0 | Immucor GTI Diagnostics Inc. 20925 Crossroads Circle, Suite 200 Waukesha, WI 53186 |
11/19/2021 |
| LIFECODES® LSA™ Class I Test, Qualitative, for HLA, Non-Diagnostic |
LIFECODES LSA Class I is a qualitative immunoassay used to detect the presence of Class I HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation, or to aid in the diagnosis of antibody mediated rejection and monitor the effectiveness of treatments designed for the removal of antibodies. | BK210573/0 | Immucor GTI Diagnostics Inc. 20925 Crossroads Circle, Suite 200 Waukesha, WI 53186 |
11/19/2021 |
| LIFECODES® LSA™ Class II Test, Qualitative, for HLA, Non-Diagnostic |
LIFECODES LSA Class II is a qualitative immunoassay used to detect the presence of Class II HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation, or to aid in the diagnosis of antibody mediated rejection and monitor the effectiveness of treatments designed for the removal of antibodies. | BK210574/0 | Immucor GTI Diagnostics Inc. 20925 Crossroads Circle, Suite 200 Waukesha, WI 53186 |
11/19/2021 |
| r-Control RBC and PLT Hematology quality control mixture |
The r-Control RBC High and Low is intended as a complete process control to monitor the process of dilution, staining and enumeration of residual leukocytes in leukocyte reduced RBC products to be used with the ADAM-rWBC Kit on the ADAM-rWBC Instrument. For in vitro diagnostic use only. The r-Control PLT High and Low is intended as a complete process control to monitor the process of dilution, staining and enumeration of residual leukocytes in leukocyte reduced PLT products to be used with the ADAM-rWBC Kit on the ADAM-rWBC Instrument. For in vitro diagnostic use only. |
BK210621/0 | NanoEntek, Inc. ------ (b)(6) ------ ------ (b)(6) ------ |
10/28/2021 |
| BloodRelay 1.1.0 Blood establishment computer software and accessories |
BloodRelay is intended to integrate with site-validated third-party systems and assist authorized and trained blood bank personnel to: Record and manage ISBT 128 blood product inventory associated information such as donation identification number (DIN), product code, expiration date/time, blood type and test results. Record and manage blood product inventory dispositions such as shipment and quarantine. Record, manage and search for patient demographic information such as name, date of birth, blood type, samples and test results. Search and locate specific blood products to facilitate tasks such as quarantining inventory to remove unsuitable units, and assist in determining compatible products based on test results. |
BK210620/0 | Alliance Technologies, LLC 1552 West Griswold Road Phoenix, AZ 85021 |
10/04/2021 |
| SoftDonor Version 4.5.5.0 Blood Establishment Computer Software and Accessories |
The SoftDonor software application supports single and multi-site blood center facilities. The software application is intended to be used by knowledgeable, trained medical personnel to document, query, and view integrated information regarding donors and products. All steps and events are captured in this decision support system including the manufacture of blood and blood components, suitability/deferral of donors, and the release of products for transfusion purposes or for further manufacturing. The system supports the use of both user or donor administered history questionnaire functionality along with additional system logic to determine donor eligibility which includes testing as well as donor health screening. The system allows manual data entry and retrieval, as well as automated data exchange by interfacing to laboratory information systems, transfusion service systems, testing facilities and recruitment systems. | BK210607/0 | SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 |
09/14/2021 |
| 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. |
BK210600/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
09/03/2021 |
| 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. |
BK210605/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
09/03/2021 |
| BTrac Blood Establishment Computer Software and Accessories |
BTrac is a computerized handheld system intended for use by hospital professionals to assist in the proper identification of patients, specimens and blood products for transfusion.
|
BK210593/0 | BIQ-Health Solutions, Lda. Rua Ferreira de Castro, 20 C Barcarena, Lisbon 2730-081 Portugal |
08/13/2021 |
| World PRP Platelet and Plasma Separator for Bone Graft Handling |
For use in the rapid preparation of autologous platelet rich plasma (PRP) from a small sample of 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. | BK210558/0 | LUVO Medical Technologies, Inc. 125 Fleming Drive Cambridge, Ontario Canada, NIT 2B8 |
07/23/2021 |
| 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:
|
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 -(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 |