Cleared Traditional

K935720 - ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM

K935720 is an FDA 510(k) clearance for ORTHO COUNT CALIBRATION KIT FOR ORTHO C..., 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 891-day FDA review.

K935720 · Ortho Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K935720

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.

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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K935720.
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
K951100 · Ortho Diagnostic Systems, Inc. · May 1996
WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
K953116 · Intl. Remote Imaging Systems · May 1996
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950482 · Ortho Diagnostic Systems, Inc. · May 1996
ABBOTT CELL-DYN 3500R SYSTEM
K960427 · Sequoia Turner Corp. · 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