# K182384: ACR  LAB Urine Analysis Test System

- Pathway: 510(k) (Traditional)
- Applicant: Healthy.Io, Ltd.
- Decided: Jul 26, 2019 after 329 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: 5 generations back to K890577 (1989). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ), ACON Laboratories, Inc. (2014) Summary page 4.

## Most influential descendants
- K252619: Qscheck Uisacr (2026), 0 descendants of its own

## Indications for use
The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

Source page: https://510kreport.com/device/K182384
Methodology: https://510kreport.com/methodology