2002 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval.
| Tradename | Description and Indication for Device | Number | Applicant | Approval Date |
|---|---|---|---|---|
| Atago SP-D2 | Donor screening at blood donation centers, to determine the total protein concentration in serum or plasma | BK010043 | VEEGEE Scientific 13600 NE 126th Place Suite A Kirkland, WA 98034 |
1/2/2002 |
| Chiron Procleix NAT Tracker 1.0E | Blood Establishment Computer Software | BK010025 | Rubin & Poor, Inc 155 Maplewood Ave Suite 5 Maplewood, NJ 07045 |
1/3/2002 |
| Hemoflow Model 400 with Data Scanner | For use in blood banks and similar settings to assist in collecting blood donations | BK010031 | Applied Science 964-B Golden Gate Terrace Grace Valley, CA 95945 |
1/23/2002 |
| Plasmapheresis Data System III 1.0 | Blood Establishment Computer Software | BK010032 | Medserv, Inc 71 South Bedford Road Mount Kisco, NY 10549 |
2/5/2002 |
| The Chiron Procleix System | Blood Establishment Computer Software | BK000051 | Gen-Probe 10210 Genetic Center Drive San Diego, CA 92121-4362 |
2/8/2002 |
| BacT/ALERT Culture Bottles | Bacterial detection systems for the recovery and detection of aerobic and anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids and platelets | BK000042 | BioMerieux, Inc 100 Akzo Avenue Durham, NC 27712 |
2/15/2002 |
| Chiron Procleix HIV-1/HCV Controls | HIV-1/HCV external quality control kits used for bloodborne pathogen testing of donors | BK010003 | Gen-Probe 10210 Genetic Center Drive San Diego, CA 92121-4362 |
2/22/2002 |
| Trima Automated Blood Component Collection System | Automated blood cell separators used for collection, pre-storage leukocyte reduction, and storage of platelet, plasma, and red blood cell products | BK010006 | Gambro BCT, Inc 10811 Collins Ave Lakewood, CO 80215-4498 |
2/27/2002 |
| Plasma Pooling Bottle II | Empty container for the collection and storage of donor plasma for further manufacture by automated plasmapheresis | BK020001 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
3/29/2002 |
| Trugene HIV-1 Genotyping Kit & Open Gene DNA Sequencing System | HIV test kit used in the detection of genomic mutations | BK020005 | Visible Genetics, Inc 700 Bay Street, Suite 1000 Toronto, CANADA |
4/24/2002 |
| Donor-ID 2.2 | Blood Establishment Computer Software | BK010049 | Digi-Trax Corp 1550 Barclay Boulevard Buffalo Grove, IL 60089 |
4/26/2002 |
| stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems | In Vitro Diagnostic use for the simultaneous identification and enumeration of CD45+ and dual-positive CD34 (CD45+/CD34+) cell population percentages and absolute counts | BK010044 | Beckman Coulter, Inc 11800 SW 147 Avenue (M/C: 31-B06) Miami, FL 33196-2500 |
5/20/2002 |
| LifeTrak Lab 2.03 | For management of data related component production, testing, and labeling of donation blood and testing of external samples | BK010052 | Mediware Information Systems, Inc 9000 Harry Hines Blvd Dallas, TX 75235 |
6/17/2002 |
| Olympus PK7200 Automated Microplate System | Fully automated analyzer used to perform donor ABO/Rh grouping, including weak D testing, syphilis and CMV qualitative screening | BK020024 | Olympus America Inc Diagnostic System Division 3131 West Royal Lane Irving, TX 75063-3104 |
7/08/2002 |
| The GAMBRO BCT Vista Information System, Independent Solution | Blood Establishment Computer Software | BK020015 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
7/15/2002 |
| Abbott Prism Retest Server 1.0 | Blood Establishment Computer Software | BK010036 | Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064-3500 |
7/17/2002 |
| Amicus Separator, Mononuclear Cell Collection | Automated blood cell separator used for the collection of mononuclear cells | BK000047 | Baxter Healthcare Corp Route 120 and Wilson Road Round Lake, IL 60073 |
7/31/2002 |
| Serology SQL LIMS 1.0 | Blood Establishment Computer Software | BK020002 | Baxter Healthcare Corp 550 North Brand Blvd Glendale, CA 91203 |
8/07/2002 |
| Biotest HLA SSP Kit | Qualitative test for HLA Class I or Class II alleles | BK020004 | Biotest Diagnostics Corp 66 Ford Road, Suite 131 Denville, NJ 07834 |
8/07/2002 |
| Amicus Separator, Concurrent Collection of Red Blood Cells | Automated Blood Cell Separator for the simultaneous collection of platelets, plasma, and red blood cells | BK000039 | Baxter Healthcare Corp Route 120 and Wilson Road Round Lake, IL 60073 US |
8/26/2002 |
| Cygnet System | Automated Blood Cell Separator to separate whole blood into its components (concurrent collection of 2 units of Red Blood Cells) | BK010033 | Baxter Healthcare Corp Route 120 and Wilson Road Round Lake, IL 60073 US |
8/27/2002 |
| SoftBank II 22 | Blood Establishment Computer Software | BK020021 | Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 |
9/11/2002 |
| VERSANT HIV-1 RNA 3.0 Assay (bDNA) | HIV detection test for the direct quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals | BP000028 | Bayer Corp P.O. Box 2466 Berkeley, CA 94702 |
9/11/2002 |
| Trima Automated Blood Collection System (Single Stage) | Automated blood cell separator-filtration | BK010046 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
9/18/2002 |
| Trima Automated Blood Collection System | Automated blood cell separator-filtration | BK010050 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
9/18/2002 |
| UltraCW (with Software version 3.13) | Blood Establishment Computer Software | BK020029 | Helmer Labs, Inc 15425 Herriman Boulevard Noblesville, IN 46060 |
10/4/2002 |
| IDM Surround Sound System, Version 3.2 | Blood Establishment Computer Software | BK020038 | Information Data Management Systems, Inc 9701 West Higgins Road Rosemont, IL 60018 |
10/8/2002 |
| BacT/ALERT SN Culture Bottles | Bacterial detection systems for the recovery and detection of aerobic and anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids and platelets | BK020022 | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
10/10/2002 |
| BacT/ALERT SA Culture Bottles | Bacterial detection systems for the recovery and detection of aerobic and anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids and platelets | BK020023 | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
10/10/2002 |
| Pall Bacterial Detection System (BDS) | For use with the Pall BDS Oxygen Analyzer in Qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of leukocyte reduced apheresis or whole blood derived platelet units | BK020014 | Medsep Corp 1630 Industrial Park Street Covina, CA 91722 |
10/22/2002 |
| System for Plasma Identification (SPI) 1.0 | Blood Establishment Computer Software | BK020020 | ZLB Bioplasma AG Wannkdorfstrasse 10 Postfach 3000 Bern, SZ |
10/30/2002 |
| OraSure OraQuick Rapid HIV-1 Antibody Test | Detection of HIV-1 antibodies in fingerstick whole blood specimens | BP010047 | OraSure Technologies, Inc 150 Webster St Bethlehem, PA 18015-1389 |
11/7/2002 |
| Trugene HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | Detection of HIV genomic mutations as an aid in monitoring and treating HIV infection Software revision included GuideLines Rules 6.0 | BK020042 | Visible Genetics, Inc 700 Bay St, Suite 1000 Toronto, CANADA |
11/7/2002 |
| Chiron Procleix System | Blood Establishment Computer Software | BK020045 | Gen-Probe 10210 Genetic Center Dr San Diego, CA 92121-42362 |
11/21/2002 |
| COBAS AmpliScreen System | For use in clinical laboratories for the automation of Polymerase Chain Reaction test procedures | BK020018 | Roche Molecular Systems, Inc 4300 Hacienda Dr PO Box 9002 Pleasanton, CA 94566-0990 |
11/26/2002 |
| ViroSeq HIV-1 Genotyping System | For use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection | BK010024 | Celera Diagnostics/Applied Biosystems, Inc 1401 Harbor Bay Parkway Alameda, CA 94502 |
12/10/2002 |
| COBAS AmpliScreen Data Output Management System (DOMS) 1.00.04 | Blood Establishment Computer Software | BK020025 | Roche Molecular Systems, Inc 4300 Hacienda Drive PO Box 9002 Pleasanton, CA 94566-0990 |
12/10/2002 |
| LeukoConnect Pre-Storage Sterile Connect Leukoreduction Set with Sepacell Filter for Red Blood Cells |
For leukoreduction of one unit of Red Blood cells in additive solution at ambient temperature within 8 hours after blood collection, or at refrigerated temperature within 72 hours after blood collection | BK020008 | Baxter Healthcare Corp - Fenwal Division Route 120 & Wilson Road Round Lake, IL 60073-0490 |
12/16/2002 |
| NucliSens HIV-1 QT RNA External Controls | Reagents with assigned values intended to be used with the NucliSens HIV-1 QT assay for quantitation of HIV-1 RNA in human plasma | BK020060 | BioMerieux, Inc 100 Rodolphe St Durham, NC 27712 |
12/18/2002 |
| MCS+ Mobile Collection System | Automated blood cell separator-filtration used in conjunction with the Single Donor Platelets Protocol and single use sterile disposable sets | BK010035 | Haemonetics Corp 400 Wood Rd Braintree, MA 02184 |
12/20/2002 |
| Cascade Medical Fibrinet, Autologous Platelet System | For the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care | BK020051 | Cascade Medical Enterprises, LLC 20 Greenup Court Wayne, NJ 07470 |
12/20/2002 |
| ALYX System | For use in blood collection establishments to collect and separate whole blood into its components | BK020056 | Baxter Healthcare Corp Route 120 & Wilson Road Round Lake, IL 60073 |
12/20/2002 |