# K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

- Pathway: 510(k) (Special)
- Applicant: Alere Technologies AS
- Decided: Sep 25, 2015 after 85 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: 3 generations back to K951361 (1995). 3 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050574: Afinion Hbalc, Axis-Shield Poc AS (2005) Summary page 4.
- K110056: Afinion Analyzer, Axis-Shield Poc AS (2011) Summary page 4.

## Most influential descendants
- 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
- K192987: Aina HbA1c Monitoring System 2 (2020), 0 descendants of its own
- K180509: Quo-Test A1c System (2019), 0 descendants of its own

## Indications for use
Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system. Alere Afinion™AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™Data Connectivity Converter (ADCC), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls 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. Alere Afinion™HbA1c Controls have been designed for use with the Alere Afinion™AS100 Analyzer System. Quality control using the Alere Afinion™HbA1c Control should be done to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable result. 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 Alere Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy. The Alere Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable results.

Source page: https://510kreport.com/device/K151809
Methodology: https://510kreport.com/methodology