ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM
FDA premarket approval P980041/S002 · decided 2002-12-06
Approval details
- PMA number
- P980041
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2002-07-22
- Decision date
- 2002-12-06
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR EXPANDING THE USE OF THE AFP IMMUNOASSAY ON THE SYNCHRON LXI 725 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME ACCESS AFP IMMUNOASSAY SYSTEM AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER. 2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD). TEST RESUL
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