Cleared Traditional

K022774 - IQ 200 SYSTEM (FDA 510(k) Clearance)

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

K022774 · Intl. Remote Imaging Systems · Pathology device
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Oct 2002
Decision
61d
Days
Class 2
Risk

K022774 is an FDA 510(k) clearance for the IQ 200 SYSTEM. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on October 21, 2002 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5200 - the FDA pathology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl. Remote Imaging Systems devices

Submission Details

510(k) Number K022774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2002
Decision Date October 21, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 77d · This submission: 61d
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 Pathology 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 K022774.
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K232416 · Arkray, Inc. · May 2024
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