Cleared Traditional

K834054 - DART GAMMA-GT REAGENT SYSTEM

K834054 is the FDA 510(k) clearance for DART GAMMA-GT REAGENT SYSTEM by Coulter Electronics, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K834054 · Coulter Electronics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
73d
Days
Class 1
Risk

K834054 is an FDA 510(k) clearance for the DART GAMMA-GT REAGENT SYSTEM. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - the FDA in vitro diagnostics and chemistry 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K834054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1983
Decision Date February 04, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQB Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 44
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K834054.
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
K850319 · Sigma Diagnostics, Inc. · Feb 1985
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720 · Data Medical Associates, Inc. · Dec 1984
SYSTEMATE 2GT - 67207
K843268 · Em Diagnostic Systems, Inc. · Sep 1984
FLOW-PAC GGT REAGENT SET
K833029 · American Research Products Co. · Dec 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001 · American Dade · Oct 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · Emd Chemicals, Inc. · Feb 1983