# K013783: Aution Max AX-4280 Urinalysis System

- Pathway: 510(k) (Traditional)
- Applicant: International Remote Imaging Systems
- Decided: Jan 18, 2002 after 65 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: 2 generations back to K943592 (1994). 3 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946183: Clinitek Atlas Automated Urine Chemistry Analyzer, Heraeus Kulzer, Inc. (1995) Summary page 1.
- K983510: Chemstrip 101 Urine Analyzer, Boehringer Mannheim Corp. (1998) Summary page 1.

## Most influential descendants
- K093098: Aution Max Model AX-4030 Urinalysis System (2009), 4 descendants of its own
- K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit (2011), 3 descendants of its own
- K171083: iChemVELOCITY Automated Urine Chemistry System (2017), 2 descendants of its own
- K030600: Aution Jet AJ-4270 Urine Analyzer (2003), 2 descendants of its own
- K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System (2021), 1 descendant of its own

## Indications for use
The AUTION MAX AX-4280 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 AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.

Source page: https://510kreport.com/device/K013783
Methodology: https://510kreport.com/methodology