2003 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 |
|---|---|---|---|---|
| Pel Freez HLA High Resolution SSP UniTray | PCR based HLA typing evaluation method designed to provide resolution of the HLA Class I (A, B, C) and Class II (DRB) Loci using genomic DNA | BK020068 | Pel-Freez Clinical Systems, LLC 9099 N. Deerbrook Trail Brown Deer, WI 53223 |
1/14/2003 |
| ALYX Component Collection System | Automated system for centrifugal blood separation - filtration | BK020059 | Baxter Healthcare Corp - Fenwal Division Route 120 & Wilson Road Round Lake, IL 60073-0490 |
1/23/2003 |
| Capture-R Ready Indicator Red Cells | Anti-IgG coated red blood cells for use in the Capture-R solid phase assays for the detection of unexpected IgG antibodies specific for antigen found on human erythrocytes. Capture-R Ready Indicator Red Cells are used in manual and semi-automated methods with Capture-R assays in the ABS2000 automated blood bank instrument | BK020053 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
1/27/2003 |
| Capture-R Control Cells | IgG-coated red cells intended to be used only with the ABS2000 blood bank analyzer to determine if the anti-IgG coated Capture-R Ready Indicator Red Cells have become neutralized | BK020054 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
1/27/2003 |
| ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer | Detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, such as an aid in monitoring and treating HIV infection | BK030005 | Applied Biosystems / Celera Diagnostics 1401 Harbor Bay Parkway Alameda, CA 94502 |
1/29/2003 |
| ASI Treponema Pallidum Hemagglutination Assay (TPHA) Test | Qualitative microhemagglutination test for the presence of IgG and IgM antibodies to Treponema pallidum (causative agent for syphilis) in serum and EDTA plasma | BK020031 | Arlington Scientific, Inc 1840 N. Technology Drive Springville, UT 84663 |
1/30/2003 |
| LOGIC 1.0 | Blood Establishment Computer Software | BK020058 | Fifth Dimension Information Systems Suite 500 Merril Lynch Tower Edmonton Centre Edmonton, Alberta, T5J 2Z2 CANADA |
2/3/2003 |
| LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells | Quality control kits for Blood Banking Reagents; to prepare and enumerate WBC in leukoreduced red blood cells and platelet products by flow cytometry | BK020063 | Beckman Coulter, Inc 11800 SW 147 Avenue (M/C: 31-B06) Miami, FL 33196-2500 |
2/3/2003 |
| LABTYPE SSO Typing Test | Qualitative test for HLA, non-diagnostic DNA typing of Class I or Class II alleles | BK020055 | One Lambda, Inc 21001 Kittridge St Conoga Park, CA 91303 |
2/4/2003 |
| Hemocare LifeLine Version, 1.0 | Blood Establishment Computer Software | BK020046 | Mediware Information Systems, Inc 900 Oakmont Lane Westmont, IL, 60659 |
2/14/2003 |
| Olympus PK TP System | Test for Syphilis and Treponema (for donor testing); to remove the PK7100 analyzer from the labeling & implement an extension of the sample age limitations for testing plasma for antibodies to Treponema pallidum | BK030007 | Fujirebio Diagnostics, Inc 201 Great Valley Parkway Malvern, PA 19355 |
2/21/2003 |
| UniMatch Plus | Qualitative test for HLA, non-diagnostic; supports evaluation of HLA typing results | BK030003 | Pel-Freez Clinical Systems, LLC 9099 N. Deerbrook Trail Brown Deer, WI, 53223 |
2/25/2003 |
| Greiner Vacuette EDTA K3 Tube | Blood specimen collection device (vacuum); for additional claim for use in immunohematology testing | BK030001 | Greiner Bio-One GmbH Greiner Vacuette North America, Inc 4238 Capital Drive Monroe, NC, 28112 |
2/26/2003 |
| SoftDonnor 4.1 | Blood Establishment Computer Software | BK020006 | Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 |
2/27/2003 |
| Transwaag Disk 01 | Blood mixing and weighing device to continuously weigh and mix blood with anticoagulation solution in the blood donation bag during the mobile or stationary collection process | BK030006 | Sarstedt, Inc P.O. Box 468 Newton, NC 28658-0468 |
2/27/2003 |
| Olympus PK7200 Automated Microplate System | Automated analyzer intended exclusively for agglutination technology using Olympus terraced microplates; can be used to perform donor ABO/Ph grouping, including weak D testing, as well as, syphilis and CMV qualitative screening | BK030009 | Olympus America, Inc Diagnostic Systems Division 3131 West Royal Lane Irving, TX 75063 |
3/3/2003 |
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | Used to update software version for additional rules and data | BK030015 | Visible Genetics, Inc 700 Bay Street Suite 1000 Toronto, Ontario M5G 1Z6 Canada |
3/14/2003 |
| NGTL Automation System (NAS) 5.2.0 | Blood Establishment Computer Software | BK020032 | American Red Cross Blood Services Quality and Regulatory Affairs Arlington, VA 22209 |
3/20/2003 |
| MedMira Rapid HIV Test | For detection of HIV-1 and HIV-2 Antibodies | BP000023 | MedMira Labs 155 Chain Lake Drive Bayers Lake Halifax, CANADA B35 1B3 |
4/16/2003 |
| SoftBank II 23 | Blood Establishment Computer Software | BK030018 | Soft Computer Consultants Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 |
4/17/2003 |
| Donor Hemoglobin Checker System | For use in conjunction with blood donor screening programs for the quantitative determination of hemoglobin in capillary, venous or arterial blood samples | BK030020 | HemoCue, Inc 9229 Cranford Drive Potomac, MD 20854 |
4/17/2003 |
| COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis | To remove mononuclear cells (MNC) or granulocytes [polymorphonuclear cells (PMN)] from a patient | BK020041 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
4/23/2003 |
| Vista Information System 2.1 | Blood Establishment Computer Software | BK030021 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
5/1/2003 |
| Leucolab LCG2 Leukoreduction System for Red Blood Cells | Leukoreduction of a single unit of red cells, at room temperature (20 to 24 °C) within 8 hours of collection, or at 1 to 6 °C up to 3 days after collection | BK030008 | Maco Pharma c/o Hoppe Regulatory Consultants 2335 Massey Lane Decatur, GA 30033 |
5/2/2003 |
| Ortho ProVue, Software Version: 2.10 | Blood Establishment Computer Software | BK030023 | Micro Typing Systems, Inc 1295 S.W. 29th Ave Pompano Beach, FL 33069 |
5/14/2003 |
| Imugard III-PL Leukocyte reduction filter | Leukocyte reduction filter for preparation of leukocyte-reduced platelets up to 3 days after collection | BK020033 | Terumo Medical Corp 125 Blue Ball Road Elkton, MD 21921 |
5/22/2003 |
| Procleix NAT Tracker | Blood Establishment Computer Software | BK030030 | Rubin and Poor, Inc 155 Maplewood Ave #5 Maplewood, NJ 07040 |
5/23/2003 |
| Vironostika HIV-1 Plus O Microelisa System | Indicated for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), including Group O, in human specimens collected as serum, plasma, or dried blood spots | BP020066 | bioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
6/6/2003 |
| ThermoGenesis Thawer | For thawing frozen plasma and frozen glycerolized red blood cells | BK030011 | Thermogenesis 3146 Gold Camp Drive Suite 206 Rancho Cordova, CA 95670-6022 |
6/10/2003 |
| ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer | Intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, such as an aid in monitoring and treating HIV infection | BK030033 | Celera Diagnostics 1401 Harbor Bay Parkway Alameda, CA 94502 |
6/11/2003 |
| Level 1 Fluid warming System | Non-electromagnetic Blood/Fluid warmer to provide rapid flow of warmed fluids | BK020043 | Level 1 Technologies, Inc 160 Weymouth Street Rockland, MA 02370 |
6/16/2003 |
| BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit | Device and assay kit that detects residual white blood cells in leukoreduced blood cell products | BK030027 | BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807 |
7/10/2003 |
| Fresenius Compomat G4 & Compomaster NT | Used for blood component separation and preparation | BK030022 | Fresenius Hemocare Inc 6675 185th Avenue NE Suite 100 Redmond, WA 98052 |
7/11/2003 |
| Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube | Evacuated blood collection tube; addition of claim for use in immunohematology testing | BK030032 | Greiner Bio-One GmbH 4238 Capital Drive Monroe, NC 28112 |
7/18/2003 |
| BacT/ALERT BPN Culture Bottle | Used the the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units; supports anaerobic growth | BK030034 | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
7/18/2003 |
| imExpress 7.2.5 | Blood Establishment Computer Software | BK020057 | Data Innovations, Inc 120 Kimball Ave, Suite 100 South Burlington, VT 05403 |
7/29/2003 |
| BacT/ALERT BPA Culture Bottle | Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units. Supports aerobic growth | BK030035 | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
8/6/2003 |
| Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 | Blood Establishment Computer Software | BK030028 | Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117-2551 |
8/19/2003 |
| Magellan Autologous Platelet Separation System | To be used in the clinical laboratory or intraoperatively at the point of care for the safe & rapid preparation of platelet poor plasma & platelet concentrate (platelet rich plasma) from a small sample of blood | BK030040 | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
9/3/2003 |
| Haemonetics Model 215 Automated Glycerolyzation/Deglycerolyzation and Cell Washing System | To glycerolize and deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for 6 days at 1-6 °C | BK030031 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
9/10/2003 |
| Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System | 7 day Platelet Storage Using Platelets Collected with COBE Spectra Apheresis Systems and the Trima Automated Blood Component Collection Systems | BK010037 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
9/24/2003 |
| OriGen Cryostore Freezing Bags | Intended to be used for blood component freezing | BK030036 | OriGen BioMedical 9709 Beck Circle Austin, TX 78758 |
10/1/2003 |
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | To market product with a revised OpenGene software incorporating the interpretation algorithm for the GuideLines Rules 8.0 | BK030052 | Bayer HealthCare Diagnostics Division 700 Bay Street Suite 1000 Toronto, Canada |
10/8/2003 |
| Donor-ID | Blood Establishment Computer Software | BK030049 | Healthcare-ID 1635 Barclay Blvd Buffalo Grove, IL 60089 |
10/31/2003 |
| Haemonetics Model 215 Automated Glycerolization/deglycerolization System | To glycerolize & deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for 6 days at 1-6°C prior to glycerolization | BK030062 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
12/10/2003 |
| HemoCue Donor Hb Checker Control | Intended for use in the verification of the precision and accuracy of the HemoCue Donor Hb Checker System | BK030067 | HemoCue, Inc 9229 Cranford Drive Potomac, MD 20854 |
12/19/2003 |
| WebLab Online Laboratory System 2.0 | Blood Establishment Computer Software | BK030065 | Mississippi Blood Services, Inc 1995 Lakeland Drive Jackson, MS 39216 |
12/22/2003 |
| Uni-Gold Recombigen HIV-1 | Detection of antibodies to HIV-1 in human serum, plasma or whole blood (venipuncture) specimens | BP030025 | Trinity Biotech Plc IDA Business Park Southern Cross Road EL, Ireland Bray, County Wicklow |
12/23/2003 |
| Aldecount Progenitor Cell Enumeration Kit | To identify and enumerate by flow cytometry low side scatter cells that express high levels of aldehyde dehydrogenase (ALDHbrSSClo) in human peripheral blood and leukapheresis samples | BK030064 | Stemco Biomedical, Inc 2810 Meridian Parkway Suite 148 Durham, NC 27713 |
12/31/2003 |
| LABScreen Products for use with LACScan 100 flow analyzer | Uses microbeads coated with HLA Class I or Class II Antogens to detect Class I/Class II HLA antibodies | BK030069 | One Lambda Inc 21001 Kittridge St Canoga Park, CA 91303 |
12/31/2003 |