Cleared Traditional

K023739 - GLUCOSE-SL-C ASSAY

K023739 is the FDA 510(k) clearance for GLUCOSE-SL-C ASSAY by Diagnostic Chemicals , Ltd.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K023739 · Diagnostic Chemicals , Ltd. · Chemistry device
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Jan 2003
Decision
71d
Days
Class 2
Risk

K023739 is an FDA 510(k) clearance for the GLUCOSE-SL-C ASSAY, MODEL 257-30. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on January 17, 2003 after a review of 71 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. devices

Submission Details

510(k) Number K023739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2002
Decision Date January 17, 2003
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K023739.
RAICHEM GLUCOSE UV (LIQUID)
K041052 · Hemagen Diagnostics, Inc. · Jun 2004
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · Dade Behring, Inc. · Jun 2003
WAKO L-TYPE GLUCOSE 2
K024281 · Wako Chemicals USA, Inc. · Feb 2003
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · Bayer Corp. · Nov 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · Hemagen Diagnostics, Inc. · Oct 2001
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · Pointe Scientific, Inc., · Nov 2000