Approval for wetcake manufacturing process changes to the advia centaur afp solid phase reagent to achieve the current hook specification of >1,000 ng/ml with an afp containing sample that is between 1,000,000 to 1,150,000 ng/ml.
| Device | ADVIA CENTAUR 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 | 2016-10-20 |
| Decision Date | 2017-04-26 |
| PMA | P930036 |
| Supplement | S007 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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