ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK
FDA premarket approval P000027/S001 · decided 2002-04-29
Approval details
- PMA number
- P000027
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2001-11-07
- Decision date
- 2002-04-29
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE ADDITION OF THE ELECSYS FREE PSA ASSAY TO THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS FREE PSA IMMUNOASSAY, ELECSYS FREE PSA CALSET AND ELECSYS FREE PSA CALCHECK AND ARE INDICATED AS FOLLOWS: IMMUNOASSAY FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA. THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELEC
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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 |