2004 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 |
|---|---|---|---|---|
| Haemonetics LN994CF·CPP·BA Extended Storage Platelet and Plasma Apheresis Set | To be used to obtain a sample of the platelets collected that is greater or equal to 4 mL | BK030084 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
1/9/2004 |
| Configurable Manual Batch Entry 1.1A | Blood Establishment Computer Software | BK030073 | Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 |
1/14/2004 |
| Trima Accel | Device modification for the Trima Automated Blood Collection System (Single Stage System) to change the operating system from QNX to VxWorks | BK030083 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
1/14/2004 |
| ViroSeq HIV-1 Genotyping System v2.0 | To detect drug resistance mutations in the protease and reverse transcriptase regions of subtype B HIV-1 with a viral load ranging from 2,000 to 750,000 RNA | BK030088 | Celera Diagnostics, LLC 1401 Harbor Bay Parkway Alameda, CA 94502 |
1/22/2004 |
| Dynal Reli SSO HLA-A Typing Kit | Provides a low to medium resolution HLA-A typing result | BK030056 | Dynal Biotech Ltd Bromborough, Wirral United Kingdom |
1/29/2004 |
| Dynal Reli SSO HLA-B Typing Kit | Provides a low to medium resolution HLA-B typing result | BK030057 | Dynal Biotech Ltd Bromborough, Wirral United Kingdom |
1/29/2004 |
| Dynal Reli SSO HLA-Cw Typing Kit | Provides a low to medium resolution HLA-Cw typing result | BK030058 | Dynal Biotech Ltd Bromborough, Wirral United Kingdom |
1/29/2004 |
| Dynal Reli SSO HLA-DQB1 Typing Kit | Provides a low to medium resolution HLA-DQB1 typing result | BK030059 | Dynal Biotech Ltd Bromborough, Wirral United Kingdom |
1/29/2004 |
| Dynal Reli SSO HLA-DRB Typing System | Provides a low to medium resolution HLA-DRB1 & DRB3/4/5 typing result | BK030060 | Dynal Biotech Ltd Bromborough, Wirral United Kingdom |
1/29/2004 |
| Pall eBDS | Intended 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 and whole blood derived platelet units | BK030082 | Medsep Corp 1630 Industrial Park Street Covina, CA 91722 |
2/4/2004 |
| Olympus PK7200 Automated Microplate System | A fully automated analyzer using agglutination technology to perform donor ABO/Rh grouping, including weak D testing | BK040003 | Olympus America Inc Diagnostic Systems Division 3131 West Royal Lane Irving, TX 75063-3104 |
2/6/2004 |
| ITL SampLok Sampling Kit | To transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests | BK030087 | ITL Corp Pty, Ltd 41-45 Tennant Street Canberra ACT 2609 Australia |
2/18/2004 |
| Haemonetics 4mL Sampling System | Intended to be sterile connected to a platelet storage container for the purpose of obtaining a 4 milliliter sample of platelets | BK040001 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
2/27/2004 |
| R&D Donor Checker Hematology Control | Designed to monitor values obtained from the HemoCue Donor Hb Checker System | BK040012 | R & D Systems, Inc 614 McKinley Place NE Minneapolis, MN 55413 |
3/5/2004 |
| BacT/ALERT BPN Culture Bottles | Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelets (LRAP) units, and leukocyte reduced single units whole blood platelet concentrates (WBPC). BacT/ALERT BPN culture bottles support the growth of anaerobic and facultative anaerobic microorganisms (bacteria) | BK030075 | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
3/8/2004 |
| BacT/ALERT BPA Culture Bottles | Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelets (LRAP) units, and leukocyte reduced single units of whole blood platelet concentrates (WBPC). BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi) | BK030076 | BioMerieux, Inc 100 Rodolphe Street Durham, NC 27712 |
3/8/2004 |
| ALYX Component Collection System and Amicus Separator System | A study of the effects of freezing or irradiation | BK030085 | Baxter Healthcare Corp - Fenwal Division Route 120 & Wilson Road Round Lake, IL 60073 |
3/15/2004 |
| Fresenius Compoguard & Donationmaster NT | Is used in blood banks for blood collection and data registration | BK040005 | Fresenius Hemocare Inc 95 Hayden Avenue Lexington, MA 02420 |
3/26/2004 |
| Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System | To be used to collect 1 unit of platelets, leukoreduced (with or without plasma). May be used to collect 2 units of platelets. The attached 4 mL sampling system used to obtain a sample of the platelets collected that is greater or equal to 4 mL | BK040020 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
3/29/2004 |
| HCLL 2.6 | Blood Establishment Computer Software | BK030078 | Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 |
4/8/2004 |
| Galileo QC Cell | Used as a negative and positive control in assays performed on the Galileo automated blood bank analyzer | BK040014 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
4/22/2004 |
| Monoclonal Control | Control for low protein Blood Grouping Reagents manufactured by Immucor and Gamma in Slide, Tube and Microplate Tests | BK040010 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
4/23/2004 |
| Galileo version 1.3.6 SP4/DMS version 1.26 | A microprocessor-controlled instrument to automate test processing, result interpretation, data management functions and immunohematology assays using a microplate based platform | BK040013 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
4/23/2004 |
| DAT Positive Control Cell | Intended to be used as a positive control in direct antiglobulin tests performed on the Galileo blood bank analyzer | BK040023 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
4/23/2004 |
| Capture-R Select Solid Phase System | Provides modified microwells for the immobilization of human erythocytes for use in solid phase assays for the detection of IgG red cell antibodies to corresponding red cell antigens | BK040024 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
4/28/2004 |
| BD Vacutainer Plus Plastic Serum Tubes with Clot Activator | To be used for immunohematology testing including but not limited to ABO grouping, Rh typing, antibody screening, red cell phenotyping and DAT testing, which requires red blood cells or serum | BK040030 | Becton, Dickinson & Company 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417-1885 |
5/5/2004 |
| Stem-Kit Reagents | For In Vitro Diagnostic Use for the simultaneous identification and enumeration of CD45+ and dual-positive CD45+ CD34+ cell population percentages and absolute counts in biological specimens by flow cytometry | BK040032 | Beckman Coulter, Inc 11800 SW 147 Avenue (M/C: 31-B06) Miami, FL 33196-2500 |
5/5/2004 |
| SoftBank II version 23 with SoftScape | Blood Establishment Computer Software | BK040028 | Soft Computer Consultants Inc 34350 U.S. HWY 19 N. Palm Harbor, FL 34684 |
5/7/2004 |
| PCS2 Plasma Collection System | Automated cell separator and blood component collector | BK040025 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
6/2/2004 |
| LD-2000 Leukocyte Counter | Intended to be used to enumerate residual leukocytes in leukocyte reduced blood products for quality control testing | BK030037 | Kowa Company, Ltd c/o Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 |
6/14/2004 |
| GPS II Platelet Concentrate Separation Kit | Designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements | BK040036 | Biomet,Inc P.O.Box 587 56 East Bell Drive Warsaw, IN 46582 |
6/18/2004 |
| Osteokin System | Preparation of platelet rich plasma | BK040017 | Orthogen Therapeutics, GmbH Graf-Adolf-Str. 43 D-40210 Dusseldorf Germany |
6/23/2004 |
| Antibody Monitoring System Class I and Class II (AMS1 and AMS1+2) | Solid Phase Enzyme linked Immunoassay for the detection of IgG Antibodies to donor-specific HLA Class I and Class II Antigens | BK040019 | GTI, Inc 20925 Crossroads Circle Waukesha, WI 53186 |
7/6/2004 |
| Haemonetics MCS+8150 Apheresis System | To allow filtration of red cells at up to 72 hours post-collection for red cells collected with the 2 RBC-F protocol on the MCS+ 8150 | BK040041 | Haemonetics Corp 400 Wood Road Braintree, MA 02184 |
7/12/2004 |
| Lifecodes LifeScreen: A Luminex 100 Screening Assay for the Detection of IgG Antibodies to HLA Class I and Class II Molecules of Human Origin | A qualitative test that can be used to detect the presence of IgG antibodies sensitized to HLA by transfusion, pregnancy or tissue transplantation | BK040034 | GTI, Inc 20925 Crossroads Circle Waukesha, WI 53186 |
7/16/2004 |
| Lifecodes ID Class I: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class I molecules | Qualitative tests that can be used to detect the presence of IgG panel reactive antibodies produced in patients sensitized to HLA Class I or Class II molecules by transfusion, pregnancy, or tissue transplantation | BK040035 | GTI, Inc 20925 Crossroads Circle Waukesha, WI 53186 |
7/16/2004 |
| Instrument Interface Engine, Version 1.0 | Blood Establishment Computer Software | BK040047 | Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 |
7/16/2004 |
| Vacuette EDTA K2 tube; Vacuette EDTA K3 tube | For use in Viral Marker Testing of blood donors | BK040018 | Sienna Partners P.O. Box 103 Baldwin, MD 21013 |
7/28/2004 |
| Chiron CPT Pooling Software, Version 2.0.0.2 | Blood Establishment Computer Software | BK040058 | Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 |
7/28/2004 |
| LabType Visual | For the evaluation of One Lambda HLA DNA typing test results | BK040049 | One Lambda, Inc 21001 Kittridge St. Canoga Park, CA 91303 |
8/9/2004 |
| SoftBank II v23.1 with Database Management System Interface (DMSI) | Blood Establishment Computer Software | BK040048 | Soft Computer Consultants, Inc 34350 U.S. HWY 19 N. Palm Harbor, FL 34684 |
8/23/2004 |
| Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes | Used for viral marker testing in screening and clinical laboratories | BK040066 | Sienna Partners P.O. Box 103 Baldwin, MD 21013 |
9/10/2004 |
| stemCXP System for the FC 500 with CXP Software | Intended for In Vitro Diagnostic Use to simultaneously identify and enumerate CD45+ and CD45+/CD34+ dual positive cell populations | BK040055 | Beckman Coulter, Inc 11800 SW 147 Avenue (M/C: 31-B06) Miami, FL 33196-2500 |
9/16/2004 |
| R & D Plasma Hemoglobin Hematology Control | To monitor values obtained from the HemoCue Plasma/Low Hemoglobin Photometer | BK040063 | R & D Systems, Inc 614 McKinley Place NE Minneapolis, MN 55413 |
9/17/2004 |
| Scansystem Bacterial Detection Device | To detect bacterial contamination in leukocyte reduced apheresis platelets (LRAP) for quality control testing | BK040031 | Hemosystem, SA 1899-A Billingsgate Circle Richmond, VA, 23223 |
9/23/2004 |
| Amicus Separator System | Intended for use for the simultaneous collection of platelet concentrate, plasma and red cells | BK040059 | Baxter Healthcare Corp - Transfusion Therapies Division Route 120 and Wilson Road Roundlake, IL 60073 |
9/24/2004 |
| LOGIC 2.0 | Blood Establishment Computer Software | BK040040 | Fifth Dimension Information Systems Suite 500, 10025- 102A Avenue Edmonton, Alberta T5J 2Z2 CANADA |
10/6/2004 |
| Check cell (Weak) | To confirm the validity of negative Antiglobulin tests obtained with Anti-Human Globulin that contains an anti-IgG components | BK040057 | Immucor, Inc 3130 Gateway Drive Norcross, GA 30091-5625 |
10/6/2004 |
| ACCURUN 315 HIV-1 RNA Positive Control | ACCURUN controls are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. ACCURUN 315 HIV-1 RNA Positive Quality Control Series [150, 200, 300, 400, 500] is formulated for use with in vitro diagnostic test methods that detect and quantitate HIV-1 RNA. ACCURUN 315 HIV-1 RNA Positive Control Series [150, 200, 300, 400, 500] is designed for a specific range of HIV-1 RNA. Additional controls at different concentrations of HIV-1 RNA are available separately from BBI | BK040006 | Boston Biomedica, Inc 375 West Street West Bridgewater, MA 02379 |
10/12/2004 |
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System | Blood Establishment Computer Software | BK040052 | Bayer HealthCare Diagnostics Division 700 Bay Street, Suite 1000 Toronto, Ontario M5G 1Z6 Canada |
10/15/2004 |
| Quality Donor System 2004 2.0 | Blood Establishment Computer Software - Quality Donor System 2004 2.0 - Computerized Donor Self-Administered Health History Questionnaire | BK040062 | Talisman Ltd 421 Church Street NE, Suite F Vienna, VA 22180 |
10/18/2004 |
| LifeTec Donor Verification and Collection System (DOVAC) 1.00 | Blood Establishment Computer Software - Life Tec Donor Verification and Collection System (DOVAC) 1.00 - Donor System Software | BK040026 | SysTec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 |
10/21/2004 |
| Blood Bank Control System (BBCS) 5.0 | Blood Establishment Computer Software - Blood Bank Control System, version 5.0 - Donor and Transfusion Services Software | BK040056 | Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 |
10/22/2004 |
| Misys Laboratory Blood Bank and Blood Donor 6.0.1 | Blood Establishment Computer Software | BK040065 | Misys Healthcare Systems 4801 East Broadway Boulevard Tucson, AZ 85711 |
10/22/2004 |
| Trima Automated Blood Component Collection System - Blood Component Sampling Accessary | To allow aseptic removal of a sample from the platelet bag for subsequent bacterial testing | BK040069 | Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
10/28/2004 |
| ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 | External run control to be used with in vitro diagnostic test kits that detect HIV-1 RNA, HCV RNA and HBV DNA | BK040064 | Boston Biomedica, Inc 375 West Street West Bridgewater, MA 02379 |
10/29/2004 |
| Procleix NAT Tracker Software Version 2.1 | Blood Establishment Computer Software | BK040072 | Chiron Corp 4560 Horton St Emeryville, CA 94608-2916 |
11/4/2004 |
| Magellan Autologous Platelet Separator System | To be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of a mixture of blood and bone marrow | BK040068 | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
11/9/2004 |
| wBlood Care 1.0 | Blood Establishment Computer Software | BK040002 | Care Fusion, Inc 1430 Spring Hill Road, Suite 510 McLean, VA 22102 |
11/10/2004 |
| Multispot HIV-1/HIV-2 Rapid Test | This device is indicated for the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 | BP040046/0 | Bio-Rad Laboratories 6565 185th Avenue NE Redmond, WA 98052 |
11/12/2004 |
| ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV) | To be used as an independent, unassayed, external run control with in vitro diagnostic tests for the detection of HIV-1 RNA, HCV RNA and HBV DNA in human serum or plasma | BK040067 | Boston Biomedica, Inc 375 West Street West Bridgewater, MA 02379 |
11/19/2004 |
| Compodock | To permit the sterile connection of 2 sterile, standard medical PVC tubing sets | BK040076 | Fresenius Hemocare Inc 95 Hayden Avenue Lexington MA 02420 |
12/17/2004 |
| ACCURUN 305 HCV RNA Positive Quality Control | To be used as an independent, unassayed, external run control with in vitro diagnostic tests for the detection of HCV RNA in human serum or plasma | BK040016 | Boston Biomedica, Inc 375 West Street West Bridgewater MA 02379 |
12/17/2004 |
| Haemonetics Model 215 Automated Glycerolization/Deglycerolization System | To submit data for a modification to the ACP215 System to support deglycerolization, using the ACP215, of red cells that have been manually glycerolized using the Valeri (40% W/V) method. Permit the sterile connection of 2 sterile, standard medical PVC tubing sets | BK040077 | Haemonetics Corp 400 Wood Road Braintree MA 02184 |
12/21/2004 |