Cleared Traditional

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (K933878) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933878 · Intracel Corp. · Hematology device
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Nov 1995
Decision
827d
Days
Class 2
Risk

K933878 is an FDA 510(k) clearance for the ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Intracel Corp. (Cambridge, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 827 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Intracel Corp. devices

Submission Details

510(k) Number K933878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1993
Decision Date November 14, 1995
Days to Decision 827 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
714d slower than avg
Panel avg: 113d · This submission: 827d
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 379
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