Cleared Traditional

VISION (TM) GGTP (K864208) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

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 9
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K864208.
GAMMA-GT
K923509 · Randox Laboratories, Ltd. · Dec 1992
ROCHE COBAS READY GGT REAGENT
K903304 · Roche Diagnostic Systems, Inc. · Oct 1990
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · Wako Chemicals USA, Inc. · Nov 1989
WAKO R-GTP C-TEST
K831639 · Wako Chemicals USA, Inc. · Jul 1983
SMA/GGT
K781533 · Technicon Instruments Corp. · Oct 1978
ULTRAZYME PLUS GT
K780099 · Harleco · Mar 1978