Approval for the acs:180 and the centaur afp assays on the advia centaur cp system. The device, as modified, will be marketed under the trade name advia centaur cp afp and is indicated for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (afp) in 1) human serum and in amniotic fluid from specimens obtained at 15 and 20 weeks gestation, as an aid in detecting open neural tube defects (ntds) when used in conjunction with ultrasonography and amniography testing 2) human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the (bayer) system.
| Device | ACS 180/ADVIA 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 | 2005-07-22 |
| Decision Date | 2005-10-07 |
| PMA | P930036 |
| Supplement | S003 |
| 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