Cleared Traditional

K002199 - MODIFICATION TO LIQUID GLUCOSE (HEXOKIN...

K002199 is the FDA 510(k) clearance for MODIFICATION TO LIQUID GLUCOSE (HEXOKIN... by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K002199 · Pointe Scientific, Inc., · Chemistry device
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Nov 2000
Decision
123d
Days
Class 2
Risk

K002199 is an FDA 510(k) clearance for the MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on November 20, 2000 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Pointe Scientific, Inc., devices

Submission Details

510(k) Number K002199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date November 20, 2000
Days to Decision 123 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
35d slower than avg
Panel avg: 88d · This submission: 123d
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 K002199.
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · Diagnostic Chemicals , Ltd. · Jan 2003
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · Bayer Corp. · Nov 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · Hemagen Diagnostics, Inc. · Oct 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
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics · Feb 2000
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999