Cleared Traditional

MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM (K012014) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012014 · Abbott Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
176d
Days
Class 2
Risk

K012014 is an FDA 510(k) clearance for the MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on December 5, 2001 after a review of 176 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 Abbott Diabetes Care, Inc. devices

Submission Details

510(k) Number K012014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date December 05, 2001
Days to Decision 176 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
88d slower than avg
Panel avg: 88d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 166
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K012014.
ACCU-CHEK ADVANTAGE MODULE
K021513 · Roche Diagnostics Corp. · Jun 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · Roche Diagnostics Corp. · Jun 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · Abbott Laboratories · Feb 2002
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · Roche Diagnostics Corp. · Dec 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · Medline Industries, Inc. · Sep 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · Roche Diagnostics Corp. · Aug 2001