Cleared Traditional

K800769 - Y-GT TEST

K800769 is the FDA 510(k) clearance for Y-GT TEST by Sclavo, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K800769 · Sclavo, Inc. · Chemistry device
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Apr 1980
Decision
17d
Days
Class 1
Risk

K800769 is an FDA 510(k) clearance for the Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 17 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 Sclavo, Inc. devices

Submission Details

510(k) Number K800769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 24, 1980
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQB Kinetic 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 - JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 44
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K800769.
ULTRAZYME-GT, ITEM #64959 & 65032
K813041 · Harleco · Nov 1981
GAMMA GLUTAMY TRANSPEPTIDASE
K812296 · Pointe Scientific, Inc., · Aug 1981
GAMMA-GT REAGENT SYSTEM
K810434 · American Monitor Corp. · Feb 1981
GAMA-GPT REAGENT SET
K780071 · Medical Analysis Systems, Inc. · Feb 1978
DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE
K761090 · Technicon Instruments Corp. · Dec 1976