Cleared Traditional

K842104 - TOYO JOZO G-GTP TEST

K842104 is an FDA 510(k) clearance for TOYO JOZO G-GTP TEST, manufactured by Advocacy International, Ltd.. The device is a Class 1 Chemistry device with product code JPZ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K842104 · Advocacy International, Ltd. · Chemistry device
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Aug 1984
Decision
77d
Days
Class 1
Risk

K842104 is an FDA 510(k) clearance for the TOYO JOZO G-GTP TEST. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Advocacy International, Ltd. (Washington, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 77 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 Advocacy International, Ltd. devices

FDA 510(k) Submission Details - K842104

510(k) Number K842104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1984
Decision Date August 10, 1984
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

JPZ Device Classification - Class 1, General Controls

Product Code JPZ Colorimetric 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 - JPZ Colorimetric Method, Gamma-glutamyl Transpeptidase

All 28
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K842104.
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
K855156 · Technostics Intl. · Jan 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET
K855186 · Technostics Intl. · Jan 1986
GLUTAMYLTRANSFERASE ASSAY KIT
K850788 · Diagnostic Chemicals, Ltd. (Usa) · Mar 1985
WAKO R-GTP C-TEST
K831639 · Wako Chemicals USA, Inc. · Jul 1983
RAICHEM & GT REAGENT
K823090 · Reagents Applications, Inc. · Nov 1982
GILCHEM Y-GT REAGENT
K822149 · Gilford Diagnostics · Aug 1982