ABBOTT ARCHITECT AFP ASSAY
FDA premarket approval P120008 · decided 2012-11-28
Approval details
- PMA number
- P120008
- Trade name
- ABBOTT ARCHITECT AFP ASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2012-05-01
- Decision date
- 2012-11-28
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ARCHITECT AFP ASSAY, ARCHITECT AFP CALIBRATORS AND ARCHITECT AFP CONTROLS. THIS DEVICE IS INDICATED FOR:THE ARCHITECT AFP ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:1) HUMAN SERUM OR PLASMA TO AID IN MONITORING DISEASE PROGRESSION DURING THE COURSE OF DISEASE AND TREATMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; AND 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION
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