2000 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 |
|---|---|---|---|---|
| Plasma Center Management System (PCMS) Vers. 2.0 | Blood Establishment Computer Software | Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
BK990046 | 1/6/2000 |
| Accurun 106 HIV-1 Antigen | Quality control kits for bloodborne pathogen testing of donors used with in vitro diagnostic tests for the detection of HIV-1 antigen | Boston Biomedicia, Inc 375 West Street West Bridgewater, MA 02379 |
BK990032 | 1/20/2000 |
| MCS+ LN8150 | Automated blood cell separator that automatically removes whole blood from a donor, separates the blood into components (RBC, white cells, plasma, and platelets), retains one or more of the components and returns the remainder to the donor | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
BK990033 | 1/20/2000 |
| Magic Client Server Ver. 5.1 | Blood Establishment Computer Software | Indico, Inc MEDITECH Circle Westwood, MA 02090 |
BK980046 | 2/8/2000 |
| RadTag | Label for blood bags to indicate that the product has been processed at the levels of irradiation currently used in the processing of blood | MEDITECH Medical Information Technology, Inc 6325 103rd Street Suite 137 Edmonton, Alberta T6G 2E1 CANADA |
BK000008 | 3/1/2000 |
| Fenwal Amicus Separator Collection of 3 Platelet Products | Automated Blood Cell Separators | Baxter Healthcare Corp Route 120 & Wilson Road Round Lake, IL 60073 |
BK990009 | 3/3/2000 |
| COBE Trima with the r/LS RBC Leukoreduction Filter | Automated Blood Cell Separators | COBE BCT 120 Oak Street Lakewood, CO 80215 |
BK990040 | 3/3/2000 |
| Ortho Lab with Ortho Lab IC (Instrument Concentrator) | Blood Establishment Computer Software | Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 P.O. Box 350 Raritan, NJ 08869-0606 |
BK990030 | 4/3/2000 |
| Information Data Management Surround System 2.0 | Blood Establishment Computer Software | Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
BK000016 | 4/7/2000 |
| COBE Trima | Intended for the collection, pre-storage leukoreduction, and storage of platelet products | COBE BCT 1201 Oak Street Lakewood, CO 80215 |
BK990025 | 4/7/2000 |
| Total Containment Device | Modification to provide for a different clamp or Taper Lock to accomodate up to nominally sized 4.3mm OD tubing | DENCO, Inc P.O. Box 9600 Wilmington, DE 19809 |
BK000022 | 4/18/2000 |
| Digi-Trax Donor-ID 2.0 | Blood Establishment Computer Software | Digi-Trax Corp 1550 Barclay Boulevard Buffalo Grove, IL 60089 |
BK000020 | 4/20/2000 |
| Capture-S Solid Phase Assay | Donor testing to detect antilipid antibodies in donor blood samples | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
BK000021 | 6/22/2000 |
| P2K Plasma Center Module 2000 Ver.1.0 | Blood Establishment Computer Software | Fifth Dimension Information Systems Suite 500 Merill Lynch Tower Edmonton Centre Edmonton, Alberta T5J 2Z2 CANADA |
BK000026 | 06/22/2000 |
| Modified Plasma Bag | Y-sampling device used to permit removal of samples from plasma bags after the collection procedure is complete | MEDSEP Corp 330 Turnbull Canyon Road City of Industry, CA 91745 |
BK000032 | 09/27/2000 |
| B-Screen Solid Phase ELISA Assay | Test system for detection of IgG antibodies to HLA Class II Antibodies | Genetic Testing Institute 150 N. Patrick Blvd Brookfield, WI 53045 |
BK990043 | 10/02/2000 |
| Quick ID Solid Phase ELISA | HLA Typing Kit to detect panel reactive HLA Class I IgG antibodies (PLA) | Genetic Testing Institute 150 N. Patrick Blvd Brookfield, WI 53045 |
BK000015 | 10/17/2000 |
| Haemonetics LN832F | Two-unit red cell disposable set with leukocyte reduction filter to collect leukocyte reduced by gravity filtration, and store 2 units of apheresis red blood cells for up to 42 days | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
BK990044 | 10/27/2000 |
| R & D Leuko-Reduced RBC Control | Automated Differential White Blood Cell Counter | R & D Systems, Inc 614 McKinley Place NE Minneapolis, MN 55413 |
BK000035 | 12/13/2000 |
| R & D Leuko-Reduced Plt Control | Automated Differential White Blood Cell Counter | R & D Systems, Inc 614 McKinley Place NE Minneapolis, MN 55413 |
BK000036 | 12/13/2000 |
| Viroclear | Quality control kits for bloodborne pathogen testing of donors | Blackhawk BioSystems, Inc 12945 Alcosta Blvd San Ramon, CA 94583 |
BK000041 | 12/28/2000 |