Cleared Traditional

K871979 - GAMMA GLUTAMYLTRANSFERASE REAGENT

K871979 is the FDA 510(k) clearance for GAMMA GLUTAMYLTRANSFERASE REAGENT by Intersect Systems, Inc.. It is a Class 1 Chemistry device (product code JPZ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K871979 · Intersect Systems, Inc. · Chemistry device
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Jun 1987
Decision
20d
Days
Class 1
Risk

K871979 is an FDA 510(k) clearance for the GAMMA GLUTAMYLTRANSFERASE REAGENT. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on June 11, 1987 after a review of 20 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K871979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1987
Decision Date June 11, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 21
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K871979.
GGT REAGENT
K905618 · Amresco, Inc. · Feb 1991
ROCHE COBAS READY GGT REAGENT
K903304 · Roche Diagnostic Systems, Inc. · Oct 1990
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · Wako Chemicals USA, Inc. · Nov 1989
VISION (TM) GGTP
K864208 · Abbott Laboratories · Nov 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K863586 · Data Medical Associates, Inc. · Oct 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K861672 · Data Medical Associates, Inc. · May 1986