Cleared Traditional

K926124 - CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON

K926124 is an FDA 510(k) clearance for CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC..., manufactured by Coulter Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K926124 · Coulter Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
214d
Days
Class 2
Risk

K926124 is an FDA 510(k) clearance for the CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Corp. (Maimi, US). The FDA issued a Cleared decision on July 6, 1993 after a review of 214 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 Coulter Corp. devices

FDA 510(k) Submission Details - K926124

510(k) Number K926124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1992
Decision Date July 06, 1993
Days to Decision 214 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 113d · This submission: 214d
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 K926124.
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · Coulter Corp. · Aug 1993
SIMULTEST CD3/ANTI-HLA-DR
K924587 · Becton Dickinson Immunocytometry Systems · Aug 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · Heraeus Kulzer, Inc. · May 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · Coulter Corp. · Jan 1993
CD4 CYTOSPHERES KIT
K921279 · Coulter Electronics, Inc. · Dec 1992