ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER

FDA premarket approval P820060/S016 · decided 2004-02-02

Approval details

PMA number: P820060
Supplement: S016
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Applicant: Abbott Laboratories
Date received: 2002-11-26
Decision date: 2004-02-02
Days to decision: 433 days
Decision code: APPR
Product code: LOJ
Advisory committee: Immunology
Expedited review: No
Location: Abbott Park, IL
Statement: APPROVAL FOR THE USE OF THE ABBOTT ARCHITECT AFP ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT ARCHITECT AFP ASSAY FOR THE ARCHITECT I2000 ANALYZER AND IS INDICATED FOR THE FOLLOWING: 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER. 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF OPEN NEURAL TUBE DEFECTS (NTD). TEST RESULTS WHEN

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