Cleared Traditional

K932532 - ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBO...

K932532 is the FDA 510(k) clearance for ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBO... by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 708-day FDA review.

K932532 · Ortho Diagnostic Systems, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
708d
Days
Class 2
Risk

K932532 is an FDA 510(k) clearance for the ORTHO-MUNE OKT8 (CD8) MONOCLONAL 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 April 26, 1995 after a review of 708 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 K932532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date April 26, 1995
Days to Decision 708 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
595d slower than avg
Panel avg: 113d · This submission: 708d
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 K932532.
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
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
K941713 · Ortho Diagnostic Systems, Inc. · Apr 1995
ONYX
K943967 · Coulter Corp. · Mar 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
K945692 · Dako Corp. · Jan 1995