Cleared Traditional

GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 (K896028) - FDA 510(k) Clearance

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

K896028 · American Research Products Co. · Chemistry device
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Nov 1989
Decision
29d
Days
Class 2
Risk

K896028 is an FDA 510(k) clearance for the GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 29 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 American Research Products Co. devices

Submission Details

510(k) Number K896028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date November 14, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K896028.
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