Cleared Traditional

K010039 - QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION

K010039 is an FDA 510(k) clearance for QUICKTEK BLOOD GLUCOSE SYSTEM, manufactured by Chronimed, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K010039 · Chronimed, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
217d
Days
Class 2
Risk

K010039 is an FDA 510(k) clearance for the QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD G.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Chronimed, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 10, 2001 after a review of 217 days - an extended review 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: 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 Chronimed, Inc. devices

FDA 510(k) Submission Details - K010039

510(k) Number K010039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2001
Decision Date August 10, 2001
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 310
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K010039.
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · Polymer Technology Systems, Inc. · Nov 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · Medline Industries, Inc. · Sep 2001
GLUCOMETER DEX TEST SENSOR
K012205 · Bayer Corp. · Sep 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · Roche Diagnostics Corp. · Aug 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · Roche Diagnostics Corp. · Jun 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · Abbott Laboratories · Jun 2001