ST AIA-PACK PA
FDA premarket approval P910065/S007 · decided 2009-11-30
Approval details
- PMA number
- P910065
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST AIA-PACK PA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Tosoh Bioscience, Inc.
- Date received
- 2009-04-24
- Decision date
- 2009-11-30
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- APPROVAL FOR ADDING THE ASSAY OF TOSOH ST AIA-PACK. PSA (PROSTATE SPECIFIC ANTIGEN) TO THE TOSOH A1A-2000 ST/LA INSTRUMENT, AND EXTENSION OF THE CALIBRATION CURVESTABILITY FOR THE ST AIA-PACK PA PSA ASSAY FROM 60 DAYS TO 90 DAYS FOR AIA NEX.IA, AIA-600 II, AIA-360, AIA-1800, AND AIA-2000.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073) | Tosoh Bioscience, Inc. | 2025-10-03 |
| ST AIA-PACK BNP Assay (K211199) | Tosoh Bioscience, Inc. | 2021-11-08 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (K200904) | Tosoh Bioscience, Inc. | 2021-08-05 |
| ST AIA-PACK hsE2 Calibrator Set (K160113) | Tosoh Bioscience, Inc. | 2016-02-17 |
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |
| ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set (K150270) | Tosoh Bioscience, Inc. | 2015-10-26 |
| ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075) | Tosoh Bioscience, Inc. | 2015-07-02 |
| AIA-PACK C-Peptide Control Set (K143296) | Tosoh Bioscience, Inc. | 2014-12-16 |