Cleared Traditional

K951100 - ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (O...

K951100 is the FDA 510(k) clearance for ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (O... by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K951100 · Ortho Diagnostic Systems, Inc. · Hematology device
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May 1996
Decision
430d
Days
Class 2
Risk

K951100 is an FDA 510(k) clearance for the ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on May 13, 1996 after a review of 430 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K951100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date May 13, 1996
Days to Decision 430 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
317d slower than avg
Panel avg: 113d · This submission: 430d
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 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K951100.
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
K960887 · Dako Corp. · May 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
K950568 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950625 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950482 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM
K935720 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
K954570 · Ortho Diagnostic Systems, Inc. · Apr 1996