Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls
FDA premarket approval P050051/S033 · decided 2019-03-06
Approval details
- PMA number
- P050051
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2017-12-21
- Decision date
- 2019-03-06
- Days to decision
- 440 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for migration of the ARCHITECT AUSAB assay, ARCHITECT AUSAB Calibrators and ARCHITECT AUSAB Controls onto the Alinity i Analyzer. The manufacture of the Alinity i analyzer would be done at a new contract manufacturer, Sanmina, Singapore.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358) | Abbott Laboratories, Inc. | 2009-08-06 |
| CREATININE (K061193) | Abbott Laboratories, Inc. | 2006-06-23 |
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |
| FOX PLUS PTA CATHETER (K040954) | Abbott Laboratories, Inc. | 2004-05-11 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT (K023062) | Abbott Laboratories, Inc. | 2002-09-30 |