Cleared Traditional

K002646 - ABX MICROS CRP

K002646 is the FDA 510(k) clearance for ABX MICROS CRP by Abx Diagnostics. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K002646 · Abx Diagnostics · Hematology device
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Oct 2000
Decision
63d
Days
Class 2
Risk

K002646 is an FDA 510(k) clearance for the ABX MICROS CRP. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx Diagnostics (Irvine, US). The FDA issued a Cleared decision on October 26, 2000 after a review of 63 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.

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Submission Details

510(k) Number K002646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2000
Decision Date October 26, 2000
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K002646.
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K992444 · Abbott Laboratories · Sep 1999
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