Cleared Traditional

K925255 - TRAX(TM) CD4 TEST KIT

K925255 is an FDA 510(k) clearance for TRAX(TM) CD4 TEST KIT, manufactured by T Cell Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 938-day FDA review.

K925255 · T Cell Diagnostics, Inc. · Hematology device
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May 1995
Decision
938d
Days
Class 2
Risk

K925255 is an FDA 510(k) clearance for the TRAX(TM) CD4 TEST KIT. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by T Cell Diagnostics, Inc. (Woburn, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 938 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 T Cell Diagnostics, Inc. devices

FDA 510(k) Submission Details - K925255

510(k) Number K925255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date May 15, 1995
Days to Decision 938 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
825d slower than avg
Panel avg: 113d · This submission: 938d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

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 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K925255.
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · Immunotech Corp. · Aug 1995
COULTER MH025A
K950949 · Coulter Corp. · Jul 1995
SYSMEX(TM) F-820, 520
K945837 · Sysmex Corp. · Jun 1995
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · Immunotech Corp. · May 1995
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
K932530 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
K932531 · Ortho Diagnostic Systems, Inc. · Apr 1995