Cleared Traditional

K945212 - MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/

K945212 is an FDA 510(k) clearance for MONOCLONAL MOUSE ANTI-HUMAN T-CELL, manufactured by Dako Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K945212 · Dako Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
458d
Days
Class 2
Risk

K945212 is an FDA 510(k) clearance for the MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-.... Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 458 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.

FDA 510(k) Submission Details - K945212

510(k) Number K945212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1994
Decision Date January 26, 1996
Days to Decision 458 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 113d · This submission: 458d
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 K945212.
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K946055 · Becton Dickinson Immunocytometry Systems · Feb 1996
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
K950342 · Becton Dickinson Immunocytometry Systems · Feb 1996
QBC ACCUREAD SYSTEM
K955504 · Becton Dickinson Diagnostic Instrument Systems · Feb 1996
CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION
K950916 · Caltag Laboratories, Inc. · Dec 1995
CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K950917 · Caltag Laboratories, Inc. · Dec 1995
CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION
K950918 · Caltag Laboratories, Inc. · Dec 1995
K945212 · MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/
Download PDF FDA Summary Dako Corp.