| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS |
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| Classification Name | kit, test, alpha-fetoprotein for neural tube defects |
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| Generic Name | chemiluminescent immunoassay for in vitro diagnostic quantitation of afp in maternal and amniotic fluid |
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| Applicant | BECKMAN COULTER, INC. |
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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 | |
| Advisory Committee |
Immunology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
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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