Cleared Traditional

GLUCOSE (HK) REAGENT, UNIVERSAL (K905227) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 35
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K905227.
ROCHE COBAS FUTURA GLUCOSE
K922811 · Roche Diagnostic Systems, Inc. · Jan 1993
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572 · Em Diagnostic Systems, Inc. · Nov 1992
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · Em Diagnostic Systems, Inc. · Jul 1991
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · Abbott Laboratories · Oct 1989
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
K894483 · Em Diagnostic Systems, Inc. · Sep 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · Em Diagnostic Systems, Inc. · Jan 1989