ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
FDA premarket approval P000027/S022 · decided 2016-03-16
Approval details
- PMA number
- P000027
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2016-02-18
- Decision date
- 2016-03-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Transfer the following manufacturing steps to a new building: Purification of antibodies and proteins and manufacturing of antibodies and proteins labelled with biotin or ruthenium complex. In addition, lyophilization of bulk raw materials necessary for production of Elecsys assays will be moved to another new building.
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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 |