ABBOTT ARCHITECT TOTAL PSA ASSAY
FDA premarket approval P910007/S010 · decided 2004-04-28
Approval details
- PMA number
- P910007
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2004-04-01
- Decision date
- 2004-04-28
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT ARCHITECT TOTAL PSA ASSAY TO BE USED ON THE ARCHITECT I2000SR PLATFORM, A MEMBER OF THE ARCHITECT I2000 INSTRUMENT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME ARCHITECT TOTAL PSA ASSAY AND IS INDICATED: THE ARCHITECT TOTAL PSA ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN [PSA-ACT]) IN HUMAN SERUM: 1) AS AN AID IN THE
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