Cleared Traditional

GLUCOSE HK-60 ASSAY KIT CAT. #201-39 (K860625) - FDA 510(k) Clearance

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

K860625 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Mar 1986
Decision
26d
Days
Class 2
Risk

K860625 is an FDA 510(k) clearance for the GLUCOSE HK-60 ASSAY KIT CAT. #201-39. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 26 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K860625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date March 17, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
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 144
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K860625.
Glucose HK Gen.3
K253490 · Roche Diagnostics · Feb 2026
Glucose2
K252357 · Abbott Ireland · Oct 2025
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134 · Roche Diagnostics · Sep 2022
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
K191899 · Roche Diagnostics · Aug 2019
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · Beckman Coulter, Inc. · Apr 2014