# K160062: AUTION ELEVEN Semi-Automated Urinalysis System

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Oct 7, 2016 after 269 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943592 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093098: Aution Max Model AX-4030 Urinalysis System, Arkray, Inc. (2009) Summary page 5.
- K030600: Aution Jet AJ-4270 Urine Analyzer, International Remote Imaging Systems (2003) Summary page 9.

## Indications for use
The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following: • AUTION ELEVEN model AE-4022 Urine Analyzer (device component) • AUTION Sticks 10EA Test Strips (reagent component)

Source page: https://510kreport.com/device/K160062
Methodology: https://510kreport.com/methodology