# K030600: Aution Jet AJ-4270 Urine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: International Remote Imaging Systems
- Decided: Jul 11, 2003 after 136 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.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983510: Chemstrip 101 Urine Analyzer, Boehringer Mannheim Corp. (1998) Summary page 1.
- K013783: Aution Max AX-4280 Urinalysis System, International Remote Imaging Systems (2002)
- K946183: Clinitek Atlas Automated Urine Chemistry Analyzer, Heraeus Kulzer, Inc. (1995) Summary page 1.

## Most influential descendants
- K160062: AUTION ELEVEN Semi-Automated Urinalysis System (2016), 0 descendants of its own
- K060280: Ichem 100 Urine Chemistry Analyzer (2006), 0 descendants of its own

## Indications for use
The AUTION™JET AJ-4270 Urine Analyzer (AUTION™JET) is a semi-automated urine analyzer and is intended for use with the AUTION™ Sticks 10EA multi-parameter test strips for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocytes, and color. The AUTION™JET Analyzer and AUTION™Sticks 10EA test strips are intended for mutually exclusive use as a system.

Source page: https://510kreport.com/device/K030600
Methodology: https://510kreport.com/methodology