Cleared Traditional

K973157 - LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE)...

K973157 is the FDA 510(k) clearance for LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE)... by Pointe Scientific, Inc.,. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K973157 · Pointe Scientific, Inc., · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
49d
Days
Class 1
Risk

K973157 is an FDA 510(k) clearance for the LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 10, 1997 after a review of 49 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K973157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date October 10, 1997
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 K973157.
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000 · Diagnostic Chemicals , Ltd. · Nov 1997
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
HICHEM Y-GT REAGENT KIT
K946192 · Hichem Diagnostics · May 1995
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · Sigma Diagnostics, Inc. · Jul 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · Stanbio Laboratory · Jul 1994