This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the architect afp assay, architect afp calibrators and architect afp controls. This device is indicated for:the architect afp assay is a chemiluminescent microparticle immunoassay (cmia) for the quantitative determination of alpha-fetoprotein (afp) in:1) human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer; and 2) human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (ntd). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open ntd. The architect afp calibrators are for the calibration of the architect i system when used for the quantitative determination of alpha-fetoprotein (afp) in human serum, plasma, and amniotic fluid. The performance of the architect afp calibrators has not been established with any other afp assays. The architect afp controls are for the estimation of test precision and the detection of systematic analytical deviations of the architect i system when used for the quantitative determination of alpha-fetoprotein (afp) in human serum, plasma, and amniotic fluid. The performance of the architect afp controls has not been established with any other afp assays.
| Device | ABBOTT ARCHITECT AFP ASSAY |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | Abbott Laboratories |
| Date Received | 2012-05-01 |
| Decision Date | 2012-11-28 |
| Notice Date | 2012-12-05 |
| PMA | P120008 |
| Supplement | S |
| Product Code | LOK |
| Docket Number | 12M-1176 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Laboratories 09v6 Ap5-2n 100 Abbott Park Road abbott Park, IL 60064 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120008 | Original Filing | |
| S021 | 2023-01-06 | 30-day Notice |
| S020 | 2022-09-14 | 30-day Notice |
| S019 | 2021-11-18 | 30-day Notice |
| S018 | 2021-11-09 | 30-day Notice |
| S017 | 2021-02-09 | Real-time Process |
| S016 | 2020-10-16 | 30-day Notice |
| S015 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S014 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | 2018-11-13 | 30-day Notice |
| S011 | ||
| S010 | 2016-10-04 | 30-day Notice |
| S009 | 2015-07-16 | 30-day Notice |
| S008 | 2015-06-15 | 30-day Notice |
| S007 | 2014-11-13 | 30-day Notice |
| S006 | 2014-03-18 | 30-day Notice |
| S005 | 2013-10-30 | 30-day Notice |
| S004 | 2013-10-28 | 30-day Notice |
| S003 | 2013-05-13 | 30-day Notice |
| S002 | 2013-02-19 | Normal 180 Day Track |
| S001 | 2013-02-11 | 30-day Notice |