# K182988: Afinion HbA1c Dx on Afinion 2

- Pathway: 510(k) (Special)
- Applicant: Alere Technologies AS
- Decided: Nov 29, 2018 after 31 days
- Product code: PDJ (Hemoglobin A1c Test System)
- Device class: 2
- Regulation: 21 CFR 862.1373
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN130002 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180296: Afinion HbA1c Dx, Alere Technologies AS (2018) Summary page 4.

## Recalls of this device
- Mar 23, 2020 · Class II · Z-2192-2020: The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.

## Indications for use
Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. The Afinion™ 2 System consisting of the Afinion™ 2 Analyser and the Afinion™ Test Cartridges is for in vitro diagnostic use only. The Afinion™ 2 Analyzer is a compact multi-assay analyzer for point-of-care testing and is designed to analyze the Afinion™ Test Cartridges.

Source page: https://510kreport.com/device/K182988
Methodology: https://510kreport.com/methodology