Cleared Special

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 (K000102) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K000102 · Teco Diagnostics · Chemistry device
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Feb 2000
Decision
26d
Days
Class 2
Risk

K000102 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on February 8, 2000 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K000102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date February 08, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
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
Modification to existing cleared device.

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 76
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K000102.
WAKO L-TYPE GLUCOSE 2
K024281 · Wako Chemicals USA, Inc. · Feb 2003
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · Bayer Corp. · Nov 2001
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
K001403 · Sigma Diagnostics, Inc. · Aug 2000
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999
GLU
K981185 · Abbott Laboratories · May 1998
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997