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 for design changes to include reduction of the incubation time from 40 to 10 minutes, change in the conjugate diluent, decrease in alp activity and change in packaging size from 200 tests to 100 tests per box. The device, as modified, will be marketed under the trade name st aia-pack pa and is indicated for: st aia-pack pa is designed for in vitro diagnostic use only for the quantitative measurement of prostate specific antigen (psa) in human serum on tosoh aia nex*ia and tosoh aia-600 ii analyzers. This device is indicated for the measurement of serum psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer (cap) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of psa in human serum to be used as an aid in the management of patients with prostatic cancer.
| Device | ST AIA-PACK PA |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | TOSOH BIOSCIENCE, INC. |
| Date Received | 2003-06-04 |
| Decision Date | 2003-08-12 |
| PMA | P910065 |
| Supplement | S004 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TOSOH BIOSCIENCE, INC. 6000 Shoreline Court suite 101 south San Francisco, CA 94080 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910065 | Original Filing | |
| S009 | 2019-05-20 | Special (immediate Track) |
| S008 | 2011-03-30 | Normal 180 Day Track |
| S007 | 2009-04-24 | Normal 180 Day Track |
| S006 | 2005-06-06 | Normal 180 Day Track |
| S005 | 2004-04-07 | Normal 180 Day Track |
| S004 | 2003-06-04 | Normal 180 Day Track |
| S003 | 2002-01-09 | Normal 180 Day Track |
| S002 | 1999-12-16 | Normal 180 Day Track |
| S001 | 1999-03-25 | Panel Track |