Approval to add the existing afp assay performed on the acs:180 to a new generation of instrumentation, the centaur and is indicated for the quantitative determination of alpha-fetoprotein (afp) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (ntds) when used in conjucntion with ultrasonography and amniography testing, using the chiron diagnostics acs:centaur(tm) automated chemiluminescence system.
| Device | ACS: CENTAUR AFP IMMUNOASSAY |
| 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 | 1998-05-01 |
| Decision Date | 1998-07-15 |
| PMA | P930036 |
| 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. 333 Coney Street east Walpole, MA 02032 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P930036 | | Original Filing |
| S020 |
2022-09-01 |
30-day Notice |
| S019 |
2022-03-22 |
30-day Notice |
| S018 |
2021-08-11 |
Real-time Process |
| S017 |
2021-07-26 |
30-day Notice |
| S016 |
2021-04-01 |
30-day Notice |
| S015 |
2020-07-31 |
30-day Notice |
| S014 |
2020-03-09 |
30-day Notice |
| S013 |
2020-02-21 |
30-day Notice |
| S012 | | |
| S011 |
2019-02-01 |
30-day Notice |
| S010 |
2018-12-06 |
Normal 180 Day Track |
| S009 |
2018-07-27 |
Real-time Process |
| S008 |
2017-09-01 |
Normal 180 Day Track |
| S007 |
2016-10-20 |
135 Review Track For 30-day Notice |
| S006 |
2015-07-17 |
Normal 180 Day Track |
| S005 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S004 |
2012-02-15 |
135 Review Track For 30-day Notice |
| S003 |
2005-07-22 |
Real-time Process |
| S002 |
2002-01-16 |
Real-time Process |
| S001 |
1998-05-01 |
Real-time Process |
NIH GUDID Devices