Cleared Traditional

K905227 - GLUCOSE (HK) REAGENT, UNIVERSAL

K905227 is an FDA 510(k) clearance for GLUCOSE (HK) REAGENT, manufactured by Enzyme Technology, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K905227 · Enzyme Technology, Inc. · Chemistry device
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Mar 1991
Decision
111d
Days
Class 2
Risk

K905227 is an FDA 510(k) clearance for the GLUCOSE (HK) REAGENT, UNIVERSAL. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Enzyme Technology, Inc. (Shelton, US). The FDA issued a Cleared decision on March 11, 1991 after a review of 111 days - within the typical 510(k) review window.

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 Enzyme Technology, Inc. devices

FDA 510(k) Submission Details - K905227

510(k) Number K905227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date March 11, 1991
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 139
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K905227.
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · Heraeus Kulzer, Inc. · Dec 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · Em Diagnostic Systems, Inc. · Jul 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · King Diagnostics, Inc. · Jul 1991
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
K901122 · Technicon Instruments Corp. · Mar 1990
COULTER GLUCOSE REAGENT
K897160 · Coulter Electronics, Inc. · Mar 1990
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028 · American Research Products Co. · Nov 1989