Cleared Traditional

AMRESCO PRODUCT NUMBER 7426 (K891923) - FDA 510(k) Clearance

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

K891923 · American Research Products Co. · Chemistry device
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Jun 1989
Decision
85d
Days
Class 2
Risk

K891923 is an FDA 510(k) clearance for the AMRESCO PRODUCT NUMBER 7426. 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 June 20, 1989 after a review of 85 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 K891923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1989
Decision Date June 20, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 88d · This submission: 85d
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 K891923.
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K894483 · Em Diagnostic Systems, Inc. · Sep 1989
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K884736 · Em Diagnostic Systems, Inc. · Jan 1989
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K884021 · Em Diagnostic Systems, Inc. · Nov 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · Abbott Laboratories · Aug 1988