2009 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.
Complete list of currently active 510k applications and PMA applications.
Note: Applications are listed with the most recent action at the top.
| Tradename | Description and Indication for Device | Number | Applicant | Approval Date |
|---|---|---|---|---|
LABScreen |
Used for the detection of antibodies to human leukocyte antigens |
BK080071 | One Lambda, Inc. |
4/10/2009 |
| FETALSCREEN™ II | A qualitative screening test for RhD ( Rho) positive fetal red blood cells in the maternal circulation |
BK080051 | Alba Bioscience 21 Ellen's Glen Road Liberton, Edinburgh EH17 7QT Scotland , UNITED KINGDOM |
4/8/2009 |
| Sunquest Blood Bank Donor 6.4 | Provides a complete transfusion service with autologous/ directed capabilities and inventory control. A permanent patient file allows for automatic retrieval of patient records, and applicable reports can be generated along with automatic capture of workload statistics. Billing information can be sent automatically to the hospital financial system | BK080042 | Sunquest Information Systems Inc. |
3/3/2009 |
| Pall Acrodose PL System |
To be used to pool and store whole-blood-derived, Leukocyte-reduced platelets in the CLX HP | BK090007 | Medsep Corporation 1630 Industrial Park Covina, CA 91722 |
2/25/2009 |
| MCS+8150 System - Wireless | The MCS+ 8150 with wireless capable modification may be used to collect the following blood components from allogeneic and autologous donors | BK090004 | Haemonetics Corporation 400 Wood Road Braintree MA 02184 -9144 |
2/20/2009 |
| Olerup SSP HLA Typing Kits | Qualitative in vitro diagnostic kits for the DNA typing of Class I and II HLA alleles. The products are used by trained professionals in medical settings for the purpose of determining HLA phenotype. The source material tested is DNA | BK080022 | Olerup SSP AB |
2/20/2009 |
| Pall eBDS | For use with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms for quality control testing of apheresis and single and pooled units of whole-blood-derived platelet products. | BK080014 | Pall Life Sciences |
2/13/2009 |
| Automated Blood Bank Analyzer | The Galileo is microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. | BK080070 | Immucor, Inc. |
2/5/2009 |
| SoftDonor 4.5 | Intended to be a decision support system used by knowledgeable users to document steps in the manufacture of blood and blood components. The software also maintains that data which blood center personnel use in making decisions regarding the suitability/deferral of donors and the release of blood or blood for transfusion purposes or for further manufacture | BK080069 | SCC Soft Computer |
1/16/2009 |
| Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells | Indicated for the leukoreduction of a single unit of AS-1 and AS-3 red cells, at room temperature (20 to 24°C) within 8 hours of collection, or AS-1, AS-3, and AS-5 red cells at 1 to 6° C up to 3 days after collection . | BK080060 | MacoProductions S.A.S. 1733 Canton Lane, Suite 103 Marietta , GA 30062-2679 |
1/14/2009 |
| TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System | The TRUGENE HIV-1 Genotyping Kit and the OpenGene DNA Sequencing System is indicated for use in detecting HIV genomic mutations in the protease and part of the reverse transcriptase regions of HIV that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. | BK080073 | Siemens Medical Solutions Diagnostics |
1/15/2009 |