| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS |
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| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
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| Applicant | Beckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822 |
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| PMA Number | P980041 |
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| Supplement Number | S001 |
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| Date Received | 06/18/2002 |
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| Decision Date | 10/01/2002 |
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| Product Code |
LOK |
| Advisory Committee |
Immunology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR EXPANDING THE USE OF THE AFP IMMUNOASSAY ON THE ACCESS 2 ANALYZER. 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 RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD. THE ASSAY IS INTENDED FOR USED IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY. |
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