Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
510(k) K151809
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151809 | Date25 Sep 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LCP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7470
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Alere Afinion HbA1c is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (HbA1c) in human whole blood. It is designed for use with the Alere Afinion AS100 Analyzer, which is a compact multi-assay analyzer for point-of-care testing.
The Alere Afinion AS100 Analyzer utilizes test cartridges and provides near patient testing. The device is factory calibrated and has received FDA 510K clearance with the product code LCP. It is manufactured by Alere Technologies AS in Oslo, Norway.
Other devices from Alere Technologies AS
Questions
AI-generated answers, 19 Sep 2026
What is the purpose of the Alere Afinion HbA1c and AS100 Analyzer?
The Alere Afinion HbA1c is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, designed for use with the Alere Afinion AS100 Analyzer, which provides near patient testing.
How is the Alere Afinion AS100 Analyzer supplied?
The Alere Afinion AS100 Analyzer utilizes test cartridges and is a compact multi-assay analyzer designed for point-of-care testing, providing near patient testing capabilities.
What is the regulatory status of the Alere Afinion HbA1c and AS100 Analyzer?
The device has received FDA 510K clearance with the product code LCP and is classified as substantially equivalent, manufactured by Alere Technologies AS in Oslo, Norway.
Is the Alere Afinion AS100 Analyzer factory calibrated?
Yes, the Alere Afinion AS100 Analyzer is factory calibrated, ensuring accurate and reliable test results for the quantitative determination of HbA1c in human whole blood.