Cleared Traditional

K864208 - VISION (TM) GGTP

K864208 is an FDA 510(k) clearance for VISION (TM) GGTP, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JPZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K864208 · Abbott Laboratories · Chemistry device
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Nov 1986
Decision
28d
Days
Class 1
Risk

K864208 is an FDA 510(k) clearance for the VISION (TM) GGTP. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 28 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K864208

510(k) Number K864208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date November 24, 1986
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 20
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K864208.
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
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K863586 · Data Medical Associates, Inc. · Oct 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K861672 · Data Medical Associates, Inc. · May 1986
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
K860723 · Trace Scientific , Ltd. · Apr 1986