ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
FDA premarket approval P100032 · decided 2011-06-27
Approval details
- PMA number
- P100032
- Trade name
- ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2010-07-30
- Decision date
- 2011-06-27
- Days to decision
- 332 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR THE ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM-HEPARIN, SODIUM-CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS
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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 |