Cleared Traditional

K912580 - FIRST CHOICE

K912580 is an FDA 510(k) clearance for FIRST CHOICE, 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 266-day FDA review.

K912580 · Polymer Technology Corp. · Chemistry device
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Mar 1992
Decision
266d
Days
Class 2
Risk

K912580 is an FDA 510(k) clearance for the FIRST CHOICE. 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 March 4, 1992 after a review of 266 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 - K912580

510(k) Number K912580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1991
Decision Date March 04, 1992
Days to Decision 266 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
178d slower than avg
Panel avg: 88d · This submission: 266d
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 K912580.
QUICK-CHECK II REAGENT STRIP
K921825 · Diagnostic Solutions, Inc. · Aug 1992
ULTRA+ BLOOD GLUCOSE TEST STRIP
K915770 · Home Diagnostics, Inc. · Apr 1992
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K915772 · Home Diagnostics, Inc. · Apr 1992
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · Lifescan, Inc. · Nov 1991
FIRST CHOICE(TM)
K912732 · Polymer Technology Corp. · Sep 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · Home Diagnostics, Inc. · Jul 1991