Cleared Traditional

K921279 - CD4 CYTOSPHERES KIT

K921279 is an FDA 510(k) clearance for CD4 CYTOSPHERES KIT, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K921279 · Coulter Electronics, Inc. · Hematology device
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Dec 1992
Decision
287d
Days
Class 2
Risk

K921279 is an FDA 510(k) clearance for the CD4 CYTOSPHERES KIT. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on December 29, 1992 after a review of 287 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 Electronics, Inc. devices

FDA 510(k) Submission Details - K921279

510(k) Number K921279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1992
Decision Date December 29, 1992
Days to Decision 287 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
174d slower than avg
Panel avg: 113d · This submission: 287d
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 K921279.
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · Coulter Corp. · Jul 1993
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K930148 · Heraeus Kulzer, Inc. · May 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · Coulter Corp. · Jan 1993
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992
COULTER MH009
K922181 · Coulter Electronics, Inc. · Aug 1992
COULTER MAXM W/ AUTOLOADER
K922704 · Coulter Electronics, Inc. · Jul 1992