Cleared Special

K000102 - GLUCOSE (HEXOKINASE) LIQUID REAGENT

K000102 is an FDA 510(k) clearance for GLUCOSE (HEXOKINASE) LIQUID REAGENT, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code CFR cleared through the Special 510(k) pathway after a 26-day FDA review.

K000102 · Teco Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K000102

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
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
Modification to existing cleared device.

CFR Device Classification - Class 2, Special Controls

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 127
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K000102.
GLUCOSE (HEXOKINASE)
K011900 · Jas Diagnostics, Inc. · Jul 2001
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · Pointe Scientific, Inc., · Nov 2000
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
N-ASSAY GLU-UL
K980883 · Crestat Diagnostics, Inc. · Sep 1998
GLU
K981185 · Abbott Laboratories · May 1998