ABBOTT ARCHITECT TOTAL PSA ASSAY
FDA premarket approval P910007/S018 · decided 2010-08-31
Approval details
- PMA number
- P910007
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT ARCHITECT TOTAL PSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2010-04-02
- Decision date
- 2010-08-31
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR INCORPORATING ADDITIONAL SPECIFIC PERFORMANCE CHARACTERISTIC INFORMATION IN REFERENCE TO PRECISION, LIMIT OF BLANK (LOB), LIMIT OF DETECTION (LOD), LIMIT OF QUANTITATION (LOQ), LINEARITY AND MEASURING INTERVAL IN THE PRODUCT LABELING FOR THE ARCHITECT TOTAL PSA ASSAY.
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