TOTAL PSA MICROTITER ELISA
FDA premarket approval P950021/S004 · decided 2002-03-19
Approval details
- PMA number
- P950021
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TOTAL PSA MICROTITER ELISA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2001-09-20
- Decision date
- 2002-03-19
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING: THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE TOTAL PSA IN HUMAN SERUM. THE ASSAY DETECTS PSA BOTH AS A FREE MOLECULE, AND WHEN COMPLEXED BY OTHER MOLECULES, PRINCIPALLY ALPHA-1-ANTICHYMOTRYPSIN (ACT). THIS DEVICE I
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