ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
FDA premarket approval P990056/S003 · decided 2006-08-10
Approval details
- PMA number
- P990056
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2006-02-13
- Decision date
- 2006-08-10
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR FORMULATION CHANGE TO THE HAMA INTERFERENCE REDUCTION PROTEINS TO IMPROVE ASSAY ROBUSTNESS WITH REGARD TO POTENTIAL HAMA INTERFERENCE FOR THE ELECSYS TOTAL PSA IMMUNOASSAY AND CHANGES IN MATRIX, ANTIGEN AND CALIBRATOR 1 TARGET VALUE FOR THE ELECSYS TOTAL PSA CALSET. THE ELECSYS TOTAL PSA CALSET, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, ELECSYS TOTAL PSA CALSET II.
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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 |