Cleared Traditional

K941315 - STANBIO Y-GT (LIQUICOLOR) TEST SET

K941315 is the FDA 510(k) clearance for STANBIO Y-GT (LIQUICOLOR) TEST SET by Stanbio Laboratory. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K941315 · Stanbio Laboratory · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
118d
Days
Class 1
Risk

K941315 is an FDA 510(k) clearance for the STANBIO Y-GT (LIQUICOLOR) TEST SET. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 118 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 Stanbio Laboratory devices

Submission Details

510(k) Number K941315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date July 14, 1994
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
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 40
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K941315.
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · Diagnostic Chemicals , Ltd. · Jun 1995
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · Sigma Diagnostics, Inc. · Jul 1994
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · Em Diagnostic Systems, Inc. · Dec 1993
SYNERMED GGT REAGENT KIT
K931958 · Synermed, Inc. · Sep 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337 · Olympus Corp. · Jan 1993