Cleared Traditional

K971145 - GLUCOSITE TEST SYSTEM

K971145 is the FDA 510(k) clearance for GLUCOSITE TEST SYSTEM by Gds Technology, LLC. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K971145 · Gds Technology, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
173d
Days
Class 2
Risk

K971145 is an FDA 510(k) clearance for the GLUCOSITE TEST SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on September 17, 1997 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Gds Technology, LLC devices

Submission Details

510(k) Number K971145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date September 17, 1997
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K971145.
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
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ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473 · Lifescan, Inc. · Dec 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556 · Lifescan, Inc. · May 1997
LIQUID GLUCOSE (OXIDASE) REAGENT SET
K970781 · Pointe Scientific, Inc., · Apr 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · Bayer Corp. · Feb 1997