Cleared Traditional

K022774 - IQ 200 SYSTEM

K022774 is an FDA 510(k) clearance for IQ 200 SYSTEM, manufactured by Intl. Remote Imaging Systems. The device is a Class 2 Pathology device with product code LKM cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K022774 · Intl. Remote Imaging Systems · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K022774

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.

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 Pathology devices follow this clearance model.

Regulatory Peers - LKM Counter, Urine Particle

All 11
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K022774.
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · Sysmex America, Inc. · May 2008
SYSMEX MODEL UF1000I
K070910 · Sysmex America, Inc. · May 2007
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
K053135 · Sysmex America, Inc. · Jan 2006
SYSMEX UF-50
K012372 · Sysmex Corp. · Sep 2001
SYSMEX UF-100
K961054 · Sysmex Corp. · Oct 1996