Cleared Traditional

K911792 - FIRST CHOICE(TM), MODIFICATION

K911792 is an FDA 510(k) clearance for FIRST CHOICE(TM), 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 23-day FDA review.

K911792 · Polymer Technology Corp. · Chemistry device
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May 1991
Decision
23d
Days
Class 2
Risk

K911792 is an FDA 510(k) clearance for the FIRST CHOICE(TM), MODIFICATION. 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 May 15, 1991 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polymer Technology Corp. devices

FDA 510(k) Submission Details - K911792

510(k) Number K911792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date May 15, 1991
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K911792.
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
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FIRST CHOICE(TM)
K912732 · Polymer Technology Corp. · Sep 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
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YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633 · Yellow Springs Instrument Co., Inc. · Apr 1991
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · Heraeus Kulzer, Inc. · Dec 1990
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · Cholestech Corp. · Dec 1990