Cleared Traditional

K020486 - CARESIDE GGT

K020486 is the FDA 510(k) clearance for CARESIDE GGT by Careside, Inc.. It is a Class 1 Chemistry device (product code JPZ) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K020486 · Careside, Inc. · Chemistry device
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Jul 2002
Decision
138d
Days
Class 1
Risk

K020486 is an FDA 510(k) clearance for the CARESIDE GGT. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Careside, Inc. devices

Submission Details

510(k) Number K020486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2002
Decision Date July 01, 2002
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
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 K020486.
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
K961919 · Data Medical Associates, Inc. · Jul 1996
GAMMA-GT
K923509 · Randox Laboratories, Ltd. · Dec 1992
KING DIAGNOSTICS GAMMA GT REAGENT
K923091 · King Diagnostics, Inc. · Sep 1992
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