Cleared Traditional

K923587 - GLUCOSE TEST SYSTEM

K923587 is an FDA 510(k) clearance for GLUCOSE TEST SYSTEM, manufactured by Polymer Technology Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K923587 · Polymer Technology Corp. · Chemistry device
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Dec 1992
Decision
188d
Days
Class 2
Risk

K923587 is an FDA 510(k) clearance for the GLUCOSE TEST SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Polymer Technology Corp. (Issaquah, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 188 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 Polymer Technology Corp. devices

FDA 510(k) Submission Details - K923587

510(k) Number K923587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date December 28, 1992
Days to Decision 188 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
100d slower than avg
Panel avg: 88d · This submission: 188d
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 306
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K923587.
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K922137 · Home Diagnostics, Inc. · Aug 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · Heraeus Kulzer, Inc. · Jun 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · Hichem Diagnostics · Apr 1993
UNI-CHECK REAGENT STRIP
K924398 · Diagnostic Solutions, Inc. · Dec 1992
ELITE TEST STRIPS GLUCOMETER
K924499 · Heraeus Kulzer, Inc. · Dec 1992
ONE TOUCH TEST STRIPS
K923544 · Lifescan, Inc. · Dec 1992