# K142262: Aution Check Plus

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Apr 10, 2015 after 239 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K874890 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874890: Quantimetrix Urine Dipstick Control, Quantimetrix Medical Industries (1988) Summary page 4.

## Indications for use
The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

Source page: https://510kreport.com/device/K142262
Methodology: https://510kreport.com/methodology