# K050574: Afinion Hbalc

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Poc AS
- Decided: Jul 22, 2005 after 137 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: 1 generation back to K951361 (1995). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951361: Dca 2000 System for Hemoglobin A1C, Heraeus Kulzer, Inc. (1995) Summary page 3.

## Most influential descendants
- K110056: Afinion Analyzer (2011), 8 descendants of its own
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (2015), 6 descendants of its own
- K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer (2017), 2 descendants of its own
- K221326: Nova Allegro HbA1c Assay, Nova Allegro Analyzer (2024), 0 descendants of its own
- K214117: Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (2023), 0 descendants of its own

## Indications for use
AfinionTM AS I00 Analyzer System, consisting of the AfinionTM AS 100 Analyzer AfinionTM Test Cartridges and AfinionTM Controls is for in-vitro diagnostic use only. AfinionTM AS 100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion TM Test Cartridges. The AfinionTM Analyzer System is easy to use, rapid and gives reliable and accurate results. AfinionTM HbAlc is an in-vitro test for quantitative determination of glycated hemoglobin in human blood. The measurement of% HbAlc is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. AfinionTM HbAlc Controls have been designed for use with the Afinion TM AS100 Analyzer System. Quality control using the AfinionTM HbA I c Control should be done to confirm that the AfinionTM AS 100 Analyzer System is working properly and provides reliable results.

Source page: https://510kreport.com/device/K050574
Methodology: https://510kreport.com/methodology