AUTION EYE™ AI-4510 Analyzer

FDA UDI

Class II (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: AUTION EYE™ AI-4510 Analyzer FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: The 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 epithilial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithilial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. FDA UDI
Model / Reference: 108861 FDA UDI
Description: The 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 epithilial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithilial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482188627 FDA UDI
510(k) Number: K232416 FDA UDI
FDA Product Code: LKM FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Urine analyser IVD, laboratory

AUTION EYE™ AI-4510 Analyzer by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K232416 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arkray Usa, Inc.

Sources (1)

FDA UDI db4aa709-b747-4883-9a28-4e9e34e2266d 36 fields · synced May 30, 2026