Cleared Traditional

K091539 - IQ 200 URINE ANALIZER BODY FLUIDS MODULE

K091539 is the FDA 510(k) clearance for IQ 200 URINE ANALIZER BODY FLUIDS MODULE by Iris Diagnostics. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K091539 · Iris Diagnostics · Hematology device
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Aug 2010
Decision
462d
Days
Class 2
Risk

K091539 is an FDA 510(k) clearance for the IQ 200 URINE ANALIZER BODY FLUIDS MODULE. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Iris Diagnostics (Chatsworth, US). The FDA issued a Cleared decision on August 31, 2010 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Iris Diagnostics devices

Submission Details

510(k) Number K091539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2009
Decision Date August 31, 2010
Days to Decision 462 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
349d slower than avg
Panel avg: 113d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
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 Hematology devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 53
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K091539.
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