Cleared Traditional

K100684 - CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (FDA 510(k) Clearance)

Class I Hematology device.

K100684 · Veridex, LLC · Hematology device
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Aug 2010
Decision
169d
Days
Class 1
Risk

K100684 is an FDA 510(k) clearance for the CELLTRACKS AUTOPREP SYSTEM MODEL:9541. Classified as Apparatus, Automated Blood Cell Diluting (product code GKH), Class I - General Controls.

Submitted by Veridex, LLC (Raritan, US). The FDA issued a Cleared decision on August 26, 2010 after a review of 169 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K100684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2010
Decision Date August 26, 2010
Days to Decision 169 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
56d slower than avg
Panel avg: 113d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GKH Apparatus, Automated Blood Cell Diluting
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.