Elecsys Anti-HBs II, PreciControl Anti-HBs
FDA premarket approval P190034/S003 · decided 2024-01-31
Approval details
- PMA number
- P190034
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Elecsys Anti-HBs II, PreciControl Anti-HBs
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics
- Date received
- 2023-08-15
- Decision date
- 2024-01-31
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the change in the name of the assay from Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck to Elecsys Anti-HBs II, PreciControl Anti-HBs.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas pulse blood glucose monitoring system (K252323) | Roche Diagnostics | 2026-06-12 |
| Elecsys Anti-SARS-CoV-2 S (K252280) | Roche Diagnostics | 2026-04-13 |
| Elecsys Anti-HBc IgM (K260049) | Roche Diagnostics | 2026-04-07 |
| Elecsys Anti-HBc II (K260046) | Roche Diagnostics | 2026-04-07 |
| Elecsys Anti-HAV IgM (K260048) | Roche Diagnostics | 2026-04-07 |
| Tina-quant Cardiac high sensitivity CRP III (K260026) | Roche Diagnostics | 2026-04-02 |
| Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490) | Roche Diagnostics | 2026-02-12 |
| ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491) | Roche Diagnostics | 2026-02-12 |