Cleared Traditional

K040077 - IMMUNICON CELLTRACKS AUTOPREP SYSTEM (FDA 510(k) Clearance)

Class I Hematology device.

K040077 · Immunicon Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
58d
Days
Class 1
Risk

K040077 is an FDA 510(k) clearance for the IMMUNICON CELLTRACKS AUTOPREP SYSTEM. Classified as Apparatus, Automated Blood Cell Diluting (product code GKH), Class I - General Controls.

Submitted by Immunicon Corp. (Huntingdon Valley, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 58 days - a notably fast clearance 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: 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 Immunicon Corp. devices

Submission Details

510(k) Number K040077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2004
Decision Date March 12, 2004
Days to Decision 58 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
55d faster than avg
Panel avg: 113d · This submission: 58d
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.