# K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer

- Pathway: 510(k) (Special)
- Applicant: Abbott Rapid Diagnostics
- Decided: Nov 21, 2017 after 169 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951361 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer, Alere Technologies AS (2015) Summary page 5.
- K050574: Afinion Hbalc, Axis-Shield Poc AS (2005) Summary page 5.
- K072409: Afinion Acr and Acr Control, Axis-Shield Poc AS (2008) Summary page 5.
- K110056: Afinion Analyzer, Axis-Shield Poc AS (2011) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1830-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the
- Jun 17, 2024 · Class II · Z-2736-2024: Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous 

## Indications for use
Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afinion™ test cartridges is for in vitro diagnostic use only. Alere Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus. The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

Source page: https://510kreport.com/device/K171650
Methodology: https://510kreport.com/methodology