Cleared Traditional

IQ 200 URINE ANALIZER BODY FLUIDS MODULE (K091539) - FDA 510(k) Clearance

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

K091539 · Iris Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 129
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K091539.
QBC HEMACAN HEMATOLOGY SYSTEM
K923121 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1992
FACSMATE SAMPLE HANDLING DEVICE
K885132 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1988
RETICCOUNT SOFTWARE
K880636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
FACS ANALYZER
K832420 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983