| 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 | IMMULITE AFP AND IMMULITE 2000 AFP |
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| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
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| Applicant | Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591 |
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| PMA Number | P010007 |
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| Supplement Number | S001 |
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| Date Received | 01/21/2003 |
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| Decision Date | 02/24/2003 |
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| Product Code |
LOK |
| Advisory Committee |
Immunology |
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| Supplement Type | Real-Time Process |
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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 USE OF THE IMMULITE AFP ON THE IMMULITE 1000 AUTOMATED ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE/IMMULITE 1000 AFP AND IS INDICATED: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AND IMMULTE 1000 ANALYZERS - FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS: (A) SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; OR (B) MEASUREMENTS IN MATERNAL SERUM AND AMNIOTIC FLUID DURING GESTATIONAL WEEKS 15 THROUGH 20 - USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY - TO AID IN DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS. |
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