Cleared Traditional

K904253 - ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY

K904253 is an FDA 510(k) clearance for ORTHO MUNE OKT3, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K904253 · Ortho Diagnostic Systems, Inc. · Hematology device
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May 1991
Decision
248d
Days
Class 2
Risk

K904253 is an FDA 510(k) clearance for the ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY. 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 20, 1991 after a review of 248 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K904253

510(k) Number K904253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1990
Decision Date May 20, 1991
Days to Decision 248 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 113d · This submission: 248d
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 296
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K904253.
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COULTER(R) MH010
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ANTI-HUMAN LEU-2A (CD8) PE
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SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
K904209 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990