ABBOTT ARCHITECT FREE PSA
FDA premarket approval P980007/S004 · decided 2004-05-07
Approval details
- PMA number
- P980007
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2004-04-01
- Decision date
- 2004-05-07
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR ADDITION OF THE ARCHITECT FREE PSA TO THE I2000SR PLATFORM, A MEMBER OF THE ARCHITECT I2000 INSTRUMENT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT FREE PSA AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THE ARCHITECT FREE PSA IS INTENDED TO BE USED IN CONJUNCTION WITH THE ARCHITECT TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DRE NON-SUS
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