Approval for use of the immulite 2000 aft on the immulite 2500 automated analyzer. The device, as modified, will be marketed under the trade name immulite 2500 afp and is indicated: "for in vitro diagnostic use with the immulite 2500 analyzers for the quantitative measurement of alpha-fetoprotein (afp) in either of two contexts: (1) serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer; or (2) 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. "
| Device | IMMULITE 2500 AFP, MODEL L5KAP |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Date Received | 2003-12-12 |
| Decision Date | 2003-12-31 |
| PMA | P010007 |
| Supplement | S002 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 Benedict Ave. tarrytown, NY 10591 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010007 | | Original Filing |
| S017 |
2022-09-15 |
30-day Notice |
| S016 | | |
| S015 |
2022-02-28 |
30-day Notice |
| S014 |
2021-04-14 |
30-day Notice |
| S013 |
2020-08-12 |
30-day Notice |
| S012 |
2020-07-23 |
30-day Notice |
| S011 |
2019-11-25 |
30-day Notice |
| S010 |
2018-09-28 |
Real-time Process |
| S009 |
2012-05-30 |
135 Review Track For 30-day Notice |
| S008 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S007 |
2011-08-16 |
30-day Notice |
| S006 |
2011-08-08 |
30-day Notice |
| S005 |
2011-02-18 |
Real-time Process |
| S004 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 |
2003-12-12 |
Real-time Process |
| S001 |
2003-01-21 |
Real-time Process |
NIH GUDID Devices