Abbott Architect Afp Assay
FDA premarket approval P120008 · Kit, Test, Alpha-Fetoprotein for Neural Tube Defects
Approval
- Applicant
- Abbott Laboratories
- Received
- May 1, 2012
- Decision date
- November 28, 2012 (APPR)
- Supplements
- 32, latest May 11, 2026
- Product code
- LOK – Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Approval order 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 TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD. THE ARCHITECT AFP CALIBRATORS ARE FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS. THE ARCHITECT AFP CONTROLS ARE FOR THE ESTIMATION OF TEST PRECISION AND THE DETECTION OF SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS.