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.
| Device | IMMULITE AFP AND IMMULITE 2000 AFP |
| 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 | 2003-01-21 |
| Decision Date | 2003-02-24 |
| PMA | P010007 |
| Supplement | S001 |
| 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