Cleared Traditional

K935720 - ORTHO COUNT CALIBRATION KIT FOR ORTHO C...

K935720 is the FDA 510(k) clearance for ORTHO COUNT CALIBRATION KIT FOR ORTHO C... by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 891-day FDA review.

K935720 · Ortho Diagnostic Systems, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
891d
Days
Class 2
Risk

K935720 is an FDA 510(k) clearance for the ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SY.... 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 9, 1996 after a review of 891 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 K935720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date May 09, 1996
Days to Decision 891 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
778d slower than avg
Panel avg: 113d · This submission: 891d
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 K935720.
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950625 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
K951100 · 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 IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
K954570 · Ortho Diagnostic Systems, Inc. · Apr 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · Dako Corp. · Mar 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · Coulter Corp. · Feb 1996