# K072409: Afinion Acr and Acr Control

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Poc AS
- Decided: Feb 12, 2008 after 169 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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 K963142 (1996). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963142: Dca 2000 + Microalbumin/Creatinine Assay, Bayer Corp. (1996) Summary page 2.

## Most influential descendants
- K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer (2017), 2 descendants of its own
- K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer (2024), 1 descendant of its own
- K252206: Nova Allegro UACR Assay, Nova Allegro Analyzer (2026), 0 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 ACR is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and albumin/creatinine ratio aids in the early diagnosis of nephropathy. AfinionTM ACR Control is a assayed in vitro diagnostic quality control material used to confirm that the AfinionTM ACR and the AfinionTM AS 100 Analyzer System is working properly and provides reliable results

Source page: https://510kreport.com/device/K072409
Methodology: https://510kreport.com/methodology