Cleared Traditional

K232416 - AUTION EYE AI-4510 Urine Particle Analysis System (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 14
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