Cleared Traditional

K940003 - VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (FDA 510(k) Clearance)

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

K940003 · Buckman Co., Inc. · Hematology device
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Oct 1995
Decision
654d
Days
Class 2
Risk

K940003 is an FDA 510(k) clearance for the VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 654 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K940003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date October 19, 1995
Days to Decision 654 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
541d slower than avg
Panel avg: 113d · This submission: 654d
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

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