Vaccines, Blood & Biologics
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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.
| Tradename | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| AMICUS Separator System with Software Version 4.3 | Blood Establishment Software | BK110030 | Fenwal Inc Three Corporate Dr 2nd Floor Lake Zurich, IL 60047 | 12/23/2011 |
| 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 | 12/23/2011 |
| Trima Accel Automated Blood Component Collection System Version 5.1.8 | Blood Establishment Software | BK110051 | CaridianBCT 10811 W. Collins Avenue Lakewood, CO 80215-4498 | 12/20/2011 |
| 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 | 12/2/2011 |
| PROCLEIX® NAT TRACKER® Version 3.0 | Blood Establishment Software | BK110060 | Novartis Vaccines and Diagnostics, Inc. 4560 Horton St. Emeryville, CA 94608-2916 | 12/1/2011 |
| 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 Leopoldshoehe D-33818 Germany | 11/17/2011 |
| DiaSpect Hemoglobin T and DiaSpect Hemoglobin Cuvettes | 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 | 11/1/2011 |
| 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 | 10/28/2011 |
| 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 | 10/19/2011 |
| Checkcell | Used as a control to confirm the validity of negative antiglobulin tests. | BK110050 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30091-5625 | 10/3/2011 |
| 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 | 9/8/2011 |
| HNA Genotyping Trays | For the molecular determination of neutrophil polymorphisms. | BK100068 | One Lambda, Inc. 21001 Kittridge St. Canoga Park, CA 91303 | 8/25/2011 |
| Fenwal DXT Relay Version 2.0 | Blood Establishment Software | BK110025 | Fenwal Inc. Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 | 8/22/2011 |
| 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 | 7/22/2011 |
| 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 | 7/14/2011 |
| 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 | 6/28/2011 |
| Nextgen 1.0.0 | Blood Establishment Software | BK110015 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 | 6/13/2011 |
| System for Plasma Identification (SPI), version 3.1.0 | Blood Establishment Software | BK110023 | CSL Behring AG Wankdorfstrasse 10 3014 Bern, SZ | 6/8/2011 |
| Trima Accel Automated Blood Component Collection System | Automated Blood Cell Separators | BK110009 | CaridianBCT 10811 W. Collins Avenue Lakewood, CO 80215-4498 | 5/31/2011 |
| ThermoGenesis Res-Q60 PRP Device | Platelet and Plasma Separator For Bone Graft Handling | BK100066 | Thermogenesis 2711 Citrus Rd Rancho Cordova, CA 95742 | 5/27/2011 |
| 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 | 4/22/2011 |
| LifeTrak/Plasma 1.0.0 | Blood Establishment Software | BK100069 | Mediware Information Systems, Inc. 11711 West 79th St Lenexa, KS 66214 | 3/4/2011 |
| 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 | 3/4/2011 |
| 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 | 2/24/2011 |
| 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 Diagnostics 511 Benedict Ave. Tarrytown, NY 10591 | 1/10/2011 |
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