Cleared Traditional

K922085 - MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM

K922085 is an FDA 510(k) clearance for MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT...., manufactured by Gen Trak, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K922085 · Gen Trak, Inc. · Hematology device
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Jul 1992
Decision
85d
Days
Class 2
Risk

K922085 is an FDA 510(k) clearance for the MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Gen Trak, Inc. (Plymouth Meeting, US). The FDA issued a Cleared decision on July 28, 1992 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gen Trak, Inc. devices

FDA 510(k) Submission Details - K922085

510(k) Number K922085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date July 28, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 113d · This submission: 85d
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 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K922085.
CD4 CYTOSPHERES KIT
K921279 · Coulter Electronics, Inc. · Dec 1992
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
COULTER MH017
K921567 · Coulter Electronics, Inc. · Jul 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K920949 · Heraeus Kulzer, Inc. · May 1992