Cleared Traditional

K944127 - CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY

K944127 is an FDA 510(k) clearance for CALTAG CD3 FITC, manufactured by Caltag Laboratories, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K944127 · Caltag Laboratories, Inc. · Hematology device
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Jun 1995
Decision
301d
Days
Class 2
Risk

K944127 is an FDA 510(k) clearance for the CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Caltag Laboratories, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 301 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K944127

510(k) Number K944127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1994
Decision Date June 20, 1995
Days to Decision 301 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 113d · This submission: 301d
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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K944127.
COULTER MH025A
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CALTAG CD4 R-PE MONOCLONAL ANTIBODY
K944128 · Caltag Laboratories, Inc. · Jun 1995
SYSMEX(TM) F-820, 520
K945837 · Sysmex Corp. · Jun 1995
TRAX(TM) CD4 TEST KIT
K925255 · T Cell Diagnostics, Inc. · May 1995
K944127 · CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY
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