# K232416: AUTION EYE AI-4510 Urine Particle Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: May 3, 2024 after 266 days
- Product code: LKM (Counter, Urine Particle)
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K093861 (2010). 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)
- K093861: IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina Cradle, Iris International, Inc. (2010) Summary page 6.

## Indications for use
AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist. The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

Source page: https://510kreport.com/device/K232416
Methodology: https://510kreport.com/methodology