Cleared Traditional

K971145 - GLUCOSITE TEST SYSTEM

K971145 is an FDA 510(k) clearance for GLUCOSITE TEST SYSTEM, manufactured by Gds Technology, LLC. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K971145

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
Combination Product No
PCCP Authorized No
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.

CGA Device Classification - Class 2, Special Controls

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 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K971145.
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K973140 · Lxn Corp. · Oct 1997
AVL OMNI ANALYZER
K972733 · Avl Scientific Corp. · Sep 1997
PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
K971812 · Medisense, Inc. · Aug 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707 · Selfcare, Inc. · Jun 1997