VIDAS TOTAL PSA
FDA premarket approval P040008/S003 · decided 2013-01-18
Approval details
- PMA number
- P040008
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VIDAS TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- bioMerieux, Inc.
- Date received
- 2012-10-11
- Decision date
- 2013-01-18
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR UPDATING THE PACKAGING INSERT BY DEFINING THE PHRASE "INSTRUMENT OF THE VIDAS FAMILY" AS "INSTRUMENT OF THE VIDAS FAMILY: VIDAS OR MINIVIDAS"AND REPLACING "INSTRUMENTS OF THE VIDAS FAMILY" WITH "VIDAS INSTRUMENTS" IN THE INTENDED USE. THE DEVICE, VIDAS® TOTAL PSA, IS INTENDED FOR USE WITH THE VIDAS INSTRUMENTS (VITEK® IMMUNODIAGNOSTIC ASSAY SYSTEM) AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OFTOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160) | bioMerieux, Inc. | 2026-07-08 |
| VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282) | bioMerieux, Inc. | 2026-04-15 |
| VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579) | bioMerieux, Inc. | 2025-08-21 |
| VITEK COMPACT PRO (K234012) | bioMerieux, Inc. | 2025-03-14 |
| VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967) | bioMerieux, Inc. | 2024-06-12 |
| VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963) | bioMerieux, Inc. | 2024-06-07 |
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000) | bioMerieux, Inc. | 2024-03-11 |