ST AIA-PACK PA
FDA premarket approval P910065/S004 · decided 2003-08-12
Approval details
- PMA number
- P910065
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST AIA-PACK PA
- 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
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- 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
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510(k) clearances by this applicant
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|---|---|---|
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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 |