ST AIA-PACK PA
FDA premarket approval P910065/S005 · decided 2004-05-25
Approval details
- PMA number
- P910065
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ST AIA-PACK PA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Tosoh Bioscience, Inc.
- Date received
- 2004-04-07
- Decision date
- 2004-05-25
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- APPROVAL OF THE TOSOH ST AIA-PACK PA ASSAY TO BE USED ON THE TOSOH AIA-360 AND TOSOH AIA-1800 AUTOMATED IMMUNOASSAY SYSTEMS, MEMBERS OF THE TOSOH AIA AUTOMATED IMMUNOASSAY SYSTEM FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME 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, AIA-600 II, AIA-1800 AND AIA-360 ANALYZERS.
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510(k) clearances by this applicant
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|---|---|---|
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073) | Tosoh Bioscience, Inc. | 2025-10-03 |
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| 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 |