Cleared Traditional

K022528 - IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ

K022528 is an FDA 510(k) clearance for IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY..., manufactured by Iq Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K022528 · Iq Corp. · Hematology device
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Sep 2002
Decision
42d
Days
Class 2
Risk

K022528 is an FDA 510(k) clearance for the IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-P.... Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Iq Corp. (Miami, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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: 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 Iq Corp. devices

FDA 510(k) Submission Details - K022528

510(k) Number K022528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2002
Decision Date September 11, 2002
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K022528.
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