ABBOTT AXSYM AFP

FDA premarket approval P820060/S011 · decided 1997-05-16

Approval details

PMA number: P820060
Supplement: S011
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Trade name: ABBOTT AXSYM AFP
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Applicant: Abbott Laboratories
Date received: 1997-04-21
Decision date: 1997-05-16
Days to decision: 25 days
Decision code: APPR
Product code: LOJ
Advisory committee: Immunology
Expedited review: No
Location: Abbott Park, IL
Statement: APPROVAL FOR THE ADDITION OF A SYSTEM PERFORMED AUTOMATED DILUTION PROTOCOL FOR A 1:101 SAMPLE DILUTION OF AMNIOTIC FLUID AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1)HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER. (2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION OT AID INT HE DETECTION OF FETAL OPEN NEURAL TUBE DETECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPH

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