Elecsys free PSA, free PSA CalSet, and free PSA CalCheck
FDA premarket approval P000027/S027 · decided 2018-07-27
Approval details
- PMA number
- P000027
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Elecsys free PSA, free PSA CalSet, and free PSA CalCheck
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2017-08-28
- Decision date
- 2018-07-27
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the migration of Elecsys free PSA, free PSA CalSet and free PSA CalCheck on the cobas e 801 immunoassay analyzer
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 |
|---|---|---|
| SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138) | Roche Diagnostics Corp. | 2013-03-15 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |
| ACCU-CHEK ULTRFLEX INFUSION SET (K101196) | Roche Diagnostics Corp. | 2010-08-27 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| ELECSYS INSULIN CALCHECK 5 (K101075) | Roche Diagnostics Corp. | 2010-06-11 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |