Premarket Approval Information - Devices
This list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Complete list of currently approved premarket approval applications.
Information is arranged in alphabetical order by the name of the applicant.
| Applicant | Product | PMA Number | Indication for Use | Approval Date |
|---|---|---|---|---|
| ABBOTT Molecular, Inc Des Plaines, IL |
Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit |
BP060002/0 | Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers | 5/11/2007 |
| Bayer Corporation Berkeley, CA |
VERSANT HIV-1 RNA 3.0 Assay (bDNA) | BP000028/0 | For the direct quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma of HIV-1 infected individuals | 9/11/2002 |
| Bayer HealthCare Tarrytown, NY |
ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents | BP050030/0 | For qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma | 5/18/2006 |
| bioMerieux, Inc Durham, NC |
NucliSens HIV-1 QT | BP010001/0 | 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 | 11/19/2001 |
| Bio-Rad Laboratories Redmond, WA |
Multispot HIV-1/HIV-2 Rapid Test | BP040046/0 | 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 | 11/12/2004 |
| Calypte Biomedical Corp Alameda, CA 94502 |
Cambridge Biotech HIV-1 Urine Western Blot | BP010009 | In vitro qualitative assay for detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) | 6/21/2001 |
| Calypte Biomedical Corp Alameda, CA 94502 |
Calypte HIV-1 Urine EIA | BP000009 | HIV detection test used in professional laboratory settings as an aid in clinical diagnosis of HIV infection | 1/12/2001 |
| CellPro, Inc Bothell, WA |
Stem Cell Concentration System | BP940001 | For the processing of autologous bone marrow to obtain a CD34+cell enriched population which is intended for hematopoietic support after myeloablative chemotherapy | 12/6/1996 |
| Chembio Diagnostic Systems, Inc Medford, NY |
SURE CHECK HIV 1/2 ASSAY | BP050009 | For the detection of antibodies to HIV 1 & 2 in fingerstick whole blood, venous whole blood, and serum or plasma specimens | 5/25/2006 |
| Chembio Diagnostic Systems, Inc Medford, NY |
HIV 1/2 STAT-PAKT ASSAY | BP050010 | For the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens | 5/25/2006 |
| Dendreon Corp. Seattle, WA |
DACS SC (Buoyant Density Solution 60) | BP970003 | Processing autologous mobilized peripheral blood progenitor cells (PBPC) collected by leukapheresis to reduce RBC, platelets and granulocytes in the final PBPC product | 7/23/1999 |
| Epitope, Inc Beaverton, OR |
OraSure HIV-1 Western Blot Kit | BP950004 | In-vitro qualitative assay for the detection of antibodies to HIV-1 in human oral fluid specimens obtained with the Orasure HIV-1 Oral Specimen Collection Device; and as an additional, more specific test for HIV-1 antibodies in OraSure specimens collected from individuals found to be repeatedly reactive by the Oral Fluid Vironostika HIV-1 Microelisa System screening test manufactured by Organon Teknika Corp | 6/3/1996 |
| Home Access Health Corp. Hoffman Estates, IL |
Home Access HIV-1 Test System | BP950002 | For self-use by people who wish to obtain anonymous HIV testing | 7/22/1996 |
| MedMira Laboratories, Inc CANADA |
MedMira Reveal Rapid HIV-1 Antibody Test | BP000023/0 | Detection of antibodies to HIV-1 in human serum or plasma speciments | 4/16/2003 |
| MedMira Labs CANADA |
MedMira Reveal G2 Rapid HIV-1 Antibody Test | BP000023/15 | To allow for the addition of a procedural and reagent control line, a change in the packaging of the Colorimetric Detection Agent, and a change in the name of the device to Reveal TM G2 Rapid HIV-1 Antibody Test | 6/23/2004 |
| Nexell Therapeutics, Inc Irvine, CA |
Isolex 300 & 300i Magnetic Cell Selection System | BP970001 & BP970001/01 | Processing autologuous peripheral blood progenitor cell (PBPC) products to obtain a CD 34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients wiht CD 34-negative tumors | 7/2/1999 |
| OraSure Technologies Bethlehem, PA |
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | BP010047/16 | Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | 6/22/2004 |
| OraSure Technologies Bethlehem, PA |
OraQuick Rapid HIV-1/2 Antibody Test | BP010047/10 | Added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen | 3/26/2004 |
| OraSure Technologies Bethlehem, PA |
OraQuick Rapid HIV-1/2 Antibody Test | BP010047/12 | Addition to the intended use statement to include detection of antibodies to HIV-2 | 3/19/2004 |
| OraSure Technologies Bethlehem, PA |
OraQuick Rapid HIV-1 Antibody Test | BP010047/7 | Allow for a labeling claim for the detection of antibodies to HIV-1 in venipuncture whole blood specimens and to reduce the maximum read time from 60 minutes to 40 minutes | 9/5/2003 |
| OraSure Technologies, Inc Bethlehem, PA |
OraQuick Rapid HIV-1 Antibody Test | BP010047 | Detection of HIV-1 antibodies in fingerstick whole blood specimens | 11/7/2002 |
| Ortho-Clinical Diagnostics, Inc Rochester, NY |
VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack |
BP050051/0 | For the in vitro detection of antibodies to Human Immunodeficiency virus types 1 and/or 2 in human serum and plasma | 3/27/2008 |
| Roche Molecular Systems, Inc Pleasanton CA |
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L | BP050069/0 | Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers | 5/11/2007 |
| Roche Molecular Systems, Inc Branchburg, NJ |
Roche Amplicor HIV-1 Monitor Test | BP950005, Supplement 3 | An aid in the management of patients on anti-viral therapy for HIV disease | 3/2/1999 |
| Roche Molecular Systems, Inc Branchburg, NJ |
Roche Amplicor HIV-1 Monitor Test | BP950005, Supplement 4 | With Ultrasensitive Processing, an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma; intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients | 3/2/1999 |
| ThermoGenesis Corp Rancho Cordova CA |
CryoSeal FS System | BP060001/0 | For use in the automated preparation of fibrin sealant from a single unit of autologous human plasma only in a closed, sterile fluid path. The autologous fibrin sealant prepared by this device is indicated for use as an adjunct to hemostasis on the incised liver surface in patients undergoing liver resection when control of bleeding by standard surgical techniques is ineffective or impractical. | 7/26/2007 |
| Trinity Biotech plc Wicklow, Ireland |
Trinity Biotech Uni-Gold Recombigen HIV Uni-Gold Recombigen HIV Positive and Negative Controls |
BP030025 / 0 | Detection of antibodies to HIV-1 in human serum, plasma or whole blood (venipuncture) specimens | 12/23/2003 |