Cleared Traditional

K860726 - ENZYMATIC GLUCOSE REAGENT SINGLE VIAL G...

K860726 is the FDA 510(k) clearance for ENZYMATIC GLUCOSE REAGENT SINGLE VIAL G... by Trace Scientific , Ltd.. It is a Class 2 Chemistry device (product code LFR) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K860726 · Trace Scientific , Ltd. · Chemistry device
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Apr 1986
Decision
54d
Days
Class 2
Risk

K860726 is an FDA 510(k) clearance for the ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on April 21, 1986 after a review of 54 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K860726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1986
Decision Date April 21, 1986
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFR Glucose Dehydrogenase, 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 - LFR Glucose Dehydrogenase, Glucose

All 47
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K860726.
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · Emd Chemicals, Inc. · Sep 1995
ADVANTAGE TEST STRIPS
K951887 · Boehringer Mannheim Corp. · Aug 1995
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · Em Diagnostic Systems, Inc. · Dec 1987
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · Em Diagnostic Systems, Inc. · Feb 1986
ULTRACHEM GLUC-DH, #65048
K821463 · Emd Chemicals, Inc. · Jun 1982
ULTRACHEM GLUC-DH, #65048
K821469 · Emd Chemicals, Inc. · Jun 1982