ELECSYS ANTI-HBC IGM TEST SYSTEM
FDA premarket approval P110022/S008 · decided 2013-12-20
Approval details
- PMA number
- P110022
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELECSYS ANTI-HBC IGM TEST SYSTEM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2012-08-31
- Decision date
- 2013-12-20
- Days to decision
- 476 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM ON THE COBAS E 601 TO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM AND IS INDICATED FOR:ELECSYS ANTI-HBC LGM IMMUNOASSAYTHE ELECSYS ANTI-HBC LGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVEDETERMINATION OFIGM ANTIBODIES TO HEPATITIS B
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 |