Cleared Traditional

K232416 - AUTION EYE AI-4510 Urine Particle Analy...

K232416 is an FDA 510(k) clearance for AUTION EYE AI-4510 Urine Particle Analy..., manufactured by Arkray, Inc.. The device is a Class 2 Immunology device with product code LKM cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K232416 · Arkray, Inc. · Immunology device
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May 2024
Decision
266d
Days
Class 2
Risk

K232416 is an FDA 510(k) clearance for the AUTION EYE AI-4510 Urine Particle Analysis System. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Arkray, Inc. (Kyoto, JP). The FDA issued a Cleared decision on May 3, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.5200 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Arkray, Inc. devices

FDA 510(k) Submission Details - K232416

510(k) Number K232416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2023
Decision Date May 03, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 104d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKM Device Classification - Class 2, Special Controls

Product Code LKM Counter, Urine Particle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LKM Counter, Urine Particle

All 8
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K232416.
iQ200 Series
K252580 · Beckman Coulter, Inc. · Sep 2025
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
K210127 · Beckman Coulter, Inc. · Jul 2021
cobas u 701 microscopy analyzer
K200811 · Roche Diagnostics · Nov 2020
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
K171883 · Sysmex America, Inc. · Apr 2018
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
K083002 · Sysmex America, Inc. · Feb 2009
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · Sysmex America, Inc. · May 2008