# K214117: Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

- Pathway: 510(k) (Dual Track)
- Applicant: Abbott Diagnostics Technologies AS
- Decided: Sep 27, 2023 after 636 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951361 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer, Abbott Rapid Diagnostics (2017) Summary page 4.
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer, Alere Technologies AS (2015) Summary page 4.

## Indications for use
Afinionm HbAlc is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin Alc, HbAlc) in venous and capillary human whole blood. The measurement of % HbAlc is recommended as a marker of long- term metabolic control in persons with diabetes mellitus. Afinionm 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinionm test cartridges. AfinionTm 2 system, consisting ofAfmion~m 2 analyzer and AfmionTM test cartridges is for in vitro diagnostic use only. Alere Afmionm AS100 Analyzer with Alere AfinionTm Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the AfinionTM Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinionm Analyzer to a laboratory information system or another electronic journal system. Alere Afmionm AS100 Analyzer System, consisting ofAlere Afinionm AS100 Analyzer with Alere Afinionm Data Connectivity Converter (ADCC), Afinionm Test Cartridges and Afinionm Controls is for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K214117
Methodology: https://510kreport.com/methodology