Cleared Traditional

K831639 - WAKO R-GTP C-TEST

K831639 is the FDA 510(k) clearance for WAKO R-GTP C-TEST by Wako Chemicals USA, Inc.. It is a Class 1 Chemistry device (product code JPZ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K831639 · Wako Chemicals USA, Inc. · Chemistry device
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Jul 1983
Decision
56d
Days
Class 1
Risk

K831639 is an FDA 510(k) clearance for the WAKO R-GTP C-TEST. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 56 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K831639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date July 18, 1983
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 20
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K831639.
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
K860723 · Trace Scientific , Ltd. · Apr 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
K860348 · Sterling Diagnostics, Inc. · Mar 1986
GLUTAMYLTRANSFERASE ASSAY KIT
K850788 · Diagnostic Chemicals, Ltd. (Usa) · Mar 1985
RAICHEM & GT REAGENT
K823090 · Reagents Applications, Inc. · Nov 1982
GILCHEM Y-GT REAGENT
K822149 · Gilford Diagnostics · Aug 1982
ULTRAZYME PLUS-GT, #64959 & 65032
K821468 · Emd Chemicals, Inc. · Jun 1982