Cleared Traditional

K100684 - CELLTRACKS AUTOPREP SYSTEM MODEL:9541

K100684 is the FDA 510(k) clearance for CELLTRACKS AUTOPREP SYSTEM MODEL:9541 by Veridex, LLC. It is a Class 1 Hematology device (product code GKH) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

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.

View all Veridex, LLC devices

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.

Regulatory Peers - GKH Apparatus, Automated Blood Cell Diluting

Devices cleared under the same product code (GKH) and FDA review panel - the closest regulatory comparables to K100684.
COULTER CELLPREP
K021150 · Beckman Coulter, Inc. · Jun 2002
COULTER MULTI Q PREP
K935953 · Coulter Corp. · Mar 1994
COULTER MULTI-Q-PREP
K923530 · Coulter Electronics, Inc. · Oct 1992
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · R&D Systems, Inc. · Oct 1984