Cleared Special

ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (K022331) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K022331 · Bayer Diagnostics Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Sep 2002
Decision
55d
Days
Class 2
Risk

K022331 is an FDA 510(k) clearance for the ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology 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.

View all Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K022331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2002
Decision Date September 11, 2002
Days to Decision 55 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

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 K022331.
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