2001 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 | Applicant | Number | Approval Date |
|---|---|---|---|---|
| Calypte HIV-1 Urine EIA | HIV detection test used in professional laboratory settings as an aid in clinical diagnosis of HIV infection | Calypte Biomedical Corp 1440 Fourth Street Berkeley, CA 94710 |
BP000009 | 1/12/2001 |
| UniTray SSP HLA Typing Kits | HLA typing kits used for resolution of HLA Class I and/or Class II loci | Pel-Freez Clinical Systems, LLC 9099 N. Deerbrook Trail Brown Deer, WI 53223 |
BK000019 | 1/29/2001 |
| GTI-MACE (Modified Capture ELISA) |
HLA typing kits used for detection of IgG antibodies to platelet glycoproteins and HLA Class I antigens | Genetic Testing Institute 150 N. Patrick Blvd Brookfield, WI 53045 |
BK000031 | 1/29/2001 |
| Harvest PRP Separation System | Blood Bank supplies used for safe and rapid preparation of platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care | Harvest Technologies 77 Accord Park Drive, D7 Norwell, MA 02061 |
BK000037 | 2/5/2001 |
| ABS2000 (ver. 1.00.30A SR-1) |
Automated blood grouping and antibody test systems used for blood grouping, antibody screening and crossmatch | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
BK010002 | 2/16/2001 |
| FluoroTrol Control Kits |
Test for residual white blood cells in leukoreduced blood components | BioErgonomics, Inc 4280 Centerville Road St. Paul, MN 55127 |
BK000046 | 4/2/2001 |
| HemoCue Low Hemoglobin Analyzing System |
Automated hemoglobin system used to determine low levels of hemoglobin in plasma, serum, aqueous solutions, or stored or banked blood using a specially designed photometer, the HemoCue Low Hemoglobin Photometer, and specially designed microcuvettes, HemoCue Low Hemoglobin Microcuvettes | HemoCue, Inc 9229 Cranford Drive Potomac, MD 20854 |
BK000043 | 4/9/2001 |
| Haemonetics LN8332F | Automated blood cell separator used to collect, leukocyte reduce (by gravity filtration), and store two units of apheresis red blood cells for up to 42 days | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
BK000048 | 4/9/2001 |
| SoftBank II Vers. 21.2 |
Blood bank transfusion service software which includes electronic crossmatch capability | Soft Computer Consultants, Inc 34350 US Highway 19N Palm Harbor, FL 34684 |
BK000040 | 4/20/2001 |
| Model 215 Automated Glycerolization and Deglycerolization System | To glycerolize and deglycerolize red blood cell products in a closed system to allow for the extended storage of the deglycerolized red blood cell product for 14 days at 4 degrees centigrade | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
BK000002 | 5/4/2001 |
| Cambridge Biotech HIV-1 Urine Western Blot | In vitro qualitative assay for detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) | Calypte Biomedical Corp 1265 Harbor Bay Parkway Alameda, CA 94502 |
BP010009 | 6/21/2001 |
| ABS2000, Version 2 Software (2.05.00A and 2.05.00B) | Automated blood test systems to perform ABO and D blood grouping, antibody detection and Immediate Spin and IgG crossmatch | Immucor Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
BK000024 | 7/3/2001 |
| System Blood Bank (SBB) Ver. 3.0 | Blood establishment computer software | Psyche Systems Corp Ten Laurel Avenue Wellesley, MA 02481 |
BK010017 | 9/4/2001 |
| IDM Surround System Ver. 3.0 | Blood establishment computer software | Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
BK010028 | 9/5/2001 |
| National Donor Deferral Registry (NDDR) Ver. 1.0 | Blood establishment computer software | American Blood Resources Association 147 Old Solomons Island Road Annapolis, MD 21401 |
BK010012 | 9/6/2001 |
| ABS2000 Ver. 1.00.30A SR-2 Ver. 2.05.00A Ver. 2.05.00B |
Blood establishment computer software | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
BK010020 | 9/24/2001 |
| TRUEGENE HIV-1 | Genotyping Kit and OpenGene DNA Sequencing System | Visible Genetics, Inc 700 BAY Street, Suite 1000 Toronto, Ontario |
BK000038 | 9/26/2001 |
| Imugard III-PL | Blood transfusion microfilters used for preparation of leukocyte-poor platelets | Terumo Medical Corp 125 Blue Ball Road Elkton, MD 21921 |
BK000045 | 9/28/2001 |
| Chiron Procleix HIV/HCV Proficiency Panel |
Quality control kits used for blood borne pathogen testing of donors | Gen-Probe 10210 Genetic Center Drive San Diego, CA 92121-4362 |
BK010005 | 10/01/2001 |
| Quik-ID Class II | Qualitative HLA test for the detection of panel reactive HLA Class II IgG antibodies (PRA) | Genetic Testing Institute 150 N. Patrick Blvd Brookfield, WI 53045 |
BK010010 | 10/01/2001 |
| MTS Incubator II | Blood bank incubated ID-MTS Gel Cards and microtest plates used for routine blood bank testing procedures | Micro Typing Systems Inc 1295 S.W. 29th Ave Pompano Beach, FL 33069 |
BK010021 | 10/01/2001 |
| Olympus PK 7200 Automated Microplate System | Automated blood grouping and antibody test system used to screen for antibodies to Treponema pallidum and CMV | Olympus America Inc Diagnostic Systems Division 3131 West Royal Lane Irvington, TX 75063-3104 |
BK010040 | 10/25/2001 |
| NucliSens HIV-1 QT | For use in conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
BP010001 | 11/19/2001 |
| Configurable Laboratory Result Manager (CLRM) Ver. 1.0E | Blood Establishment Computer Software | Rubin & Poor, Inc 155 Maplewood Avenue, #5 Maplewood, NJ 07040 |
BK000030 | 11/23/2001 |
| Chiron CPT Pooling Software, Vers. 2.0.0.2 | Blood Establishment Computer Software | Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 |
BK000049 | 12/4/2001 |
| Apheresis Data Integration System (ADIS) | Blood Establishment Computer Software | Baxter Healthcare Corp Route 120 and Wilson Road Round Lake, IL 60073 |
BK010016 | 12/4/2001 |
| Transwaag KL | Blood device that continuously weighs and mixes blood with the anticoagulant solution in the blood donation bag during the collection process | Sarstedt, Inc P.O. Box 468 Newton, NC 28658-0468 |
BK010042 | 12/12/2001 |
| Accurun 1 Multimarker Negative Control | Quality control kits for blood banking reagents used as an independent, external run control with in vitro test for HIV, HTLV, HBcAg, antibodies to HCV, antibodies to CMV, antibodies to syphilis, HBsAg, and HIV-1 antigen | Boston Biomedica, Inc 375 West Street West Bridgewater, MA 02379 |
BK010038 | 12/18/2001 |
| Sahara Blood and Plasma Warming Device | Blood and plasma warming device used to thaw or warm blood products for infusion/transfusion filled in plastic bags | Sarstedt, Inc P.O. Box 468 Newton, NC 28658-0468 |
BK010045 | 12/21/2001 |