This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the addition of an assay protocol file to the assay software of the access afp reagent for on-board system auto-dilution of human serum and amniotic fluid samples for all access immunoassay anlayzers (access, access 2, synchron lxi 725 and unicel dxi 800). The access afp assay is a paramagnetic particle, chemiluminescent immunoassay for the use with the access immunoassay systems for the quantitative determination of alpha-fetoprotein (afp) in: 1) human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2) maternal serum and amniotic fluid at 15 to20 weeks gestation, to aid in the detection of fetal open neural tube defects (ontd). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ontd. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
| Device | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2004-07-29 |
| Decision Date | 2004-08-04 |
| PMA | P980041 |
| Supplement | S006 |
| 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 | BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980041 | Original Filing | |
| S049 | 2020-09-30 | Real-time Process |
| S048 | 2020-07-22 | Real-time Process |
| S047 | 2020-06-23 | Real-time Process |
| S046 | 2019-12-18 | Real-time Process |
| S045 | 2019-05-13 | Real-time Process |
| S044 | 2019-05-02 | Real-time Process |
| S043 | ||
| S042 | ||
| S041 | 2018-09-25 | Real-time Process |
| S040 | 2018-08-13 | 30-day Notice |
| S039 | 2017-09-28 | 30-day Notice |
| S038 | ||
| S037 | 2017-06-09 | 30-day Notice |
| S036 | 2017-03-22 | Real-time Process |
| S035 | 2017-01-17 | 30-day Notice |
| S034 | 2016-06-10 | 135 Review Track For 30-day Notice |
| S033 | 2015-06-05 | 30-day Notice |
| S032 | 2015-05-07 | Real-time Process |
| S031 | 2014-11-10 | 30-day Notice |
| S030 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S029 | 2014-08-25 | Real-time Process |
| S028 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S027 | 2013-12-17 | Real-time Process |
| S026 | 2013-09-26 | Special (immediate Track) |
| S025 | 2013-06-13 | Special (immediate Track) |
| S024 | 2013-04-12 | Special (immediate Track) |
| S023 | 2013-03-29 | Real-time Process |
| S022 | 2013-01-23 | Real-time Process |
| S021 | 2013-01-03 | 30-day Notice |
| S020 | ||
| S019 | ||
| S018 | 2012-10-25 | Special (immediate Track) |
| S017 | 2012-03-15 | Special (immediate Track) |
| S016 | 2011-12-23 | Real-time Process |
| S015 | 2011-01-12 | Special (immediate Track) |
| S014 | 2011-01-10 | Special (immediate Track) |
| S013 | 2010-09-27 | Normal 180 Day Track |
| S012 | 2008-05-27 | Real-time Process |
| S011 | 2008-02-26 | Special (immediate Track) |
| S010 | 2007-09-07 | Real-time Process |
| S009 | 2007-05-30 | Normal 180 Day Track |
| S008 | 2006-04-10 | Real-time Process |
| S007 | 2006-01-18 | 30-day Notice |
| S006 | 2004-07-29 | Real-time Process |
| S005 | 2004-07-01 | 30-day Notice |
| S004 | 2003-12-02 | Normal 180 Day Track No User Fee |
| S003 | 2002-12-04 | Real-time Process |
| S002 | 2002-07-22 | Normal 180 Day Track |
| S001 | 2002-06-18 | Normal 180 Day Track |