ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK
FDA premarket approval P000027/S002 · decided 2003-02-24
Approval details
- PMA number
- P000027
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2002-10-11
- Decision date
- 2003-02-24
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR DESIGN CHANGES TO MODIFY THE COMPOSITION AND VOLUMES OF THE REAGENTS, AND LABELING CHANGES TO ADD CLAIMS FOR THE USE OF LITHIUM AND NH4-HEPARIN PLASMA SAMPLES, TO ELIMINATE THE RECOMMENDATION FOR NA CITRATE PLASMA, AND TO OMIT THE SAMPLE DILUTION CLAIM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS FREE PSA IMMUNOASSAY AND IS INDICATED FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA. THE ELECSYS FREE PS
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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 |