Cleared Traditional

K935984 - GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419

K935984 is an FDA 510(k) clearance for GLUTAMYL-TRANSFERASE, manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JQB cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K935984 · Sigma Diagnostics, Inc. · Chemistry device
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Jul 1994
Decision
218d
Days
Class 1
Risk

K935984 is an FDA 510(k) clearance for the GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 218 days - an extended review 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: 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K935984

510(k) Number K935984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1993
Decision Date July 20, 1994
Days to Decision 218 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
130d slower than avg
Panel avg: 88d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

JQB Device Classification - Class 1, General Controls

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 51
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K935984.
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · Diagnostic Chemicals , Ltd. · Jun 1995
HICHEM Y-GT REAGENT KIT
K946192 · Hichem Diagnostics · May 1995
GGT QVET
K942962 · Prisma Systems · Dec 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · Stanbio Laboratory · Jul 1994
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · Em Diagnostic Systems, Inc. · Dec 1993
SYNERMED GGT REAGENT KIT
K931958 · Synermed, Inc. · Sep 1993