Cleared Traditional

K860625 - GLUCOSE HK-60 ASSAY KIT CAT. #201-39

K860625 is the FDA 510(k) clearance for GLUCOSE HK-60 ASSAY KIT CAT. #201-39 by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

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
Combination Product No
PCCP Authorized No
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 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K860625.
GLUCOSE HK PROCEDURE
K863259 · Data Medical Associates, Inc. · Sep 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · Sterling Diagnostics, Inc. · Apr 1986
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)
K860724 · Trace Scientific , Ltd. · Apr 1986
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826 · Catachem, Inc. · Sep 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464 · Medical Analysis Systems, Inc. · Sep 1985
PDA GLUCOSE
K843541 · Abbott Laboratories · Sep 1984