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 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P980041 |
Supplement Number | S006 |
Date Received | 07/29/2004 |
Decision Date | 08/04/2004 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE ADDITION OF AN ASSAY PROTOCOL FILE TO THE ASSAY SOFTWARE OF THE ACCESS AFP REAGENT FOR ON-BOARD SYSTEM AUTO-DILUTION OF HUMAN SERUM AND AMNIOTIC FLUID SAMPLES FOR ALL ACCESS IMMUNOASSAY ANLAYZERS (ACCESS, ACCESS 2, SYNCHRON LXI 725 AND UNICEL DXI 800). THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE USE WITH THE ACCESS IMMUNOASSAY SYSTEMS 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 TO20 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 USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY. |
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