Cleared Traditional

K912580 - FIRST CHOICE

K912580 is the FDA 510(k) clearance for FIRST CHOICE by Polymer Technology Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K912580 · Polymer Technology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K912580.
ACCUDATA GLUCOSE TEST STATION
K924475 · Boehringer Mannheim Corp. · Oct 1992
IL TEST GLUCOSE, PN 181633-80
K922532 · Instrumentation Laboratory CO · Sep 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888 · Lifescan, Inc. · Sep 1992
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · Lifescan, Inc. · Nov 1991
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · Heraeus Kulzer, Inc. · Dec 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292 · Boehringer Mannheim Corp. · Oct 1990