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Vaccines, Blood & Biologics

2011 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.

2011 Biological Device Application Approvals
Tradename Description and Indication for Device Submission ID Manufacturer Clearance
AMICUS Separator System with Software Version 4.3 Blood Establishment Software
BK110030 Fenwal Inc
Three Corporate Dr
2nd Floor
Lake Zurich, IL 60047
Clotalyst Kit with GPS(R)III Separator Used for the safe and rapid
preparation of autologous
platelet-rich plasma (PRP) from a small sample of the patient's blood at the point of care. The PRP can be mixed with autograft
or allograft bone prior to
application to an orthopedic
surgical site as deemed
necessary by the clinical
requirements. The Clotalyst Kit is designed for the preparation of autologous serum that is to be
mixed with the PRP and autograft or allograft for bone graft handling
prior to application to the
orthopedic site.
BK110040 Biomet Biologics, Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581-0587
Trima Accel Automated Blood
Component Collection System
Version 5.1.8
Blood Establishment Software BK110051 CaridianBCT
10811 W. Collins Avenue
Lakewood, CO 80215-4498
LIFECODES HLA Typing Kits are qualitative tests (in vitro diagnostic kits) for the DNA typing of Class I and Class II HLA alleles. The products are used by trained professionals in medical setting for the purpose of determining HLA phenotype. The source of material tested is DNA. No
component of the kit comes in direct contact with the patient. DNA typings are not the sole tests upon which a clinical decision
affecting the patient is based; a cross-match is routinely required. These kits are intended for In Vitro Diagnostic (IVD) use.
BK110002  Gen-Probe
550 West Avenue
Stanford, CT 06902 
Version 3.0
Blood Establishment Software BK110060 Novartis Vaccines and Diagnostics, Inc.
4560 Horton St.
Emeryville, CA 94608-2916 
Plasmatherm A thawing and heating device intended for the following applications: timed heating of whole blood and blood products; thawing and timed heating of fresh frozen plasma conserves; thawing and timed heating of HPC (haematopoietic progenitor cells); heating and maintaining the warmth of non-denaturable infusion solutions and other
materials in continuous operation.
BK100063 Barkey GmbH & Co KG
Gewerbestrasse 8
D-33818  Germany
DiaSpect Hemoglobin T and DiaSpect Hemoglobin
Designed for quantitative total hemoglobin determination in human blood donation settings, using capillary or venous samples in a specially designed analyzer, the Diaspect Hemoglobin T analyzer, with specially designed, disposable microcuvettes, DiaSpect Hemoglobin Cuvettes. The Diaspect Hemoglobin T analyzer is only to be used with Diaspect Hemoglobin Cuvettes. For in vitro diagnostic use only. BK110036 Diaspect Medical GMBH
800 E. Leigh Street
Suite 206-5
Richmond, VA 23219
Sepax Cell Separation and Single Use Kits Intended for laboratory use in exclusive combination with a compatible single-use separation kit supplied by Biosafe. BK110022 Biosafe SA
Route du Petit-Eysins
Eysins, Switzerland
BD Stem Cell Enumeration Kit Provides simultaneous enumeration of viable dual-positive CD45+/CD34+ hematopoietic stem cell populations in CD34+ absolute counts (cells/μL) as well as the percentage of the total viable leukocyte count that is CD34+ (%CD34). The following specimens can be analyzed with this kit: normal and mobilized peripheral blood, fresh and thawed leukopheresis products, fresh and thawed bone marrow, and fresh and thawed cord blood. The kit is intended for in vitro diagnostic (IVD) use on either a BD FACSCalibur™ flow cytometer using BD CellQuest™ or BD CellQuest™ Pro software or a BD FACSCanto™ II flow cytometer using BD FACSCanto™ software. BK110037

BD iosciences

2350 Qume Drive
San Jose, CA 95131-1807

Checkcell Used as a control to confirm the validity of negative antiglobulin tests.  BK110050 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30091-5625
Platelet PGD Test System  For the detection of aerobic and anaerobiv Gram-positive and Gram-negative bacteria in LRAP and pools of 6 units of Leukocyte reduced and non-leukocyte reduced whole blood derived platelets. BK110014 Verax Biomedical Incorporated
377 Plantation St. Biotech 4
Worcester, MA 01605
HNA Genotyping Trays  For the molecular determination of neutrophil polymorphisms. BK100068 One Lambda, Inc.
21001 Kittridge St.
Canoga Park, CA 91303
Fenwal DXT Relay Version 2.0  Blood Establishment Software BK110025 Fenwal Inc.
Three Corporate Drive, 2nd Floor
Lake Zurich, IL 60047
GS HIV Combo Ag/Ab EIA An enzyme immunoassay kit for the simultaneous qualitative detection of Human Immunodeficiency
Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2) in human serum or plasma. This kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in both adult and pediatric subjects. The GS HIV Combo Ag/Ab EIA is intended for manual
use and with the Bio-Rad EVOLIS Automated Microplate System. 
BP100064 Bio-Rad Laboratories
6565 185th Ave., NE
Redmond, WA 98052 
Ortho ProVue Analyzer Version 3.1 Patch 1 (V3.1.1) A modular, microprocessor controlled instrument designed to automate in vitro immunohematological testing of human blood utilizing the ID-MTS Gel Card technology. As a standalone instrument or
interface to the customer'sLaboratory Information System (LIS), the Ortho ProVue Analyzer
automates test processing functions and data management requirements using gel cards and
digital image processing.
BK110029 Micro Typing Systems Inc.
1295 S.W. 29th Ave.Pompano Beach, FL 33069
Ortho Summit System (OSS) A modular, integrated system for use with licensed blood screening test. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and Ortho Assay Software. OSS automates many of the processing functions and data management requirements associated with enzyme-linked immunosorbent assay microplate testing. BK110026 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
Nextgen 1.0.0 Blood Establishment Software BK110015 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
System for Plasma
Identification (SPI), version 3.1.0

Blood Establishment Software BK110023 CSL Behring AG
Wankdorfstrasse 10
3014 Bern, SZ
Trima Accel Automated Blood
Component Collection System
Automated Blood Cell
BK110009 CaridianBCT
10811 W. Collins Avenue
Lakewood, CO 80215-4498
ThermoGenesis Res-Q60 PRP
Platelet and Plasma
Separator For Bone Graft
BK100066 Thermogenesis
2711 Citrus Rd
Rancho Cordova, CA 95742
Boekel Plasma Thawer, Model 301000 A thawing bath intended for use in blood banks and laboratories where it is required to thaw up to four units of frozen plasma. BK100051 Boekel Scientific, Inc.
855 Pennsylvania Blvd.
Feasterville, PA 19053
LifeTrak/Plasma 1.0.0  Blood Establishment Software BK100069 Mediware Information Systems, Inc.
11711 West 79th St
Lenexa, KS  66214
TRUGENE HIV-1 Genotyping
Kit and OpenGene DNA Sequencing System
For use in detecting HIV genomic mutations in the protease and part of the reverse transcriptase region of HIV that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection.  BK110007 Siemens Healthcare
Diagnostics Inc.
P.O. Box 2466
Berkeley, CA 94702
The Pall Celeris fPC System 

*For the rapid preparation of autologous platelet concentrate (PC) from a small sample of blood at the patient's point of care. The PC can be mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.

*Please note the above information was originally posted with the incorrect description and indication for use. The corrected information is in the current posting.

BK100058 Medsep Corp
1630 Industrial Park
Covina, CA 91722
ADVIA Centaur® HIV 1/O/2 Enhanced Assay An in vitro diagnostic immunoassay for the qualitative determination of antibodies to the human immunodeficiency virus type 1, including group O, and/or type 2 in serum or plasma using the ADVIA Centaur System. BP050030/013 Siemens Healthcare
511 Benedict Ave.
Tarrytown, NY 10591

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