ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET
FDA premarket approval P990056/S001 · decided 2002-02-08
Approval details
- PMA number
- P990056
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2001-10-09
- Decision date
- 2002-02-08
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE ADDITION OF THE ASSAY TO THE MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS TOTAL PSA IMMUNOASSAY AND ELECSYS TOTAL PSA CALSET AND ARE INDICATED AS FOLLOWS: THE ELECSYS TOTAL PSA IMMUNOASSAY, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA, IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (D
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 |