Cleared Special

K093861 - IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

K093861 is an FDA 510(k) clearance for IQ 20 SERIES ANALYZER, manufactured by Iris International, Inc.. The device is a Class 2 Pathology device with product code LKM cleared through the Special 510(k) pathway after a 51-day FDA review.

K093861 · Iris International, Inc. · Pathology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
51d
Days
Class 2
Risk

K093861 is an FDA 510(k) clearance for the IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on February 5, 2010 after a review of 51 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093861

510(k) Number K093861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2009
Decision Date February 05, 2010
Days to Decision 51 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 78d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

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 14
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K093861.
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
SYSMEX MODEL UF1000I
K070910 · Sysmex America, Inc. · May 2007
K093861 · IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
Download PDF FDA Summary Iris International, I…