# K093098: Aution Max Model AX-4030 Urinalysis System

- Pathway: 510(k) (Special)
- Applicant: Arkray, Inc.
- Decided: Dec 23, 2009 after 83 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- 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 K943592 (1994). 4 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013783: Aution Max AX-4280 Urinalysis System, International Remote Imaging Systems (2002) Summary page 1.

## Most influential descendants
- K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own
- K193514: AUTION MAX AX-4060 Urinalysis System (2023), 0 descendants of its own
- K160062: AUTION ELEVEN Semi-Automated Urinalysis System (2016), 0 descendants of its own
- K121456: Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control (2013), 0 descendants of its own

## Indications for use
The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTLON MAX is intended for use only with AUTLON Sticks 9EB multi-parameter test strips.

Source page: https://510kreport.com/device/K093098
Methodology: https://510kreport.com/methodology