Cleared Traditional

K012324 - ACCU-CHEK ACTIVE TEST SYSTEM

K012324 is the FDA 510(k) clearance for ACCU-CHEK ACTIVE TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K012324 · Roche Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
135d
Days
Class 2
Risk

K012324 is an FDA 510(k) clearance for the ACCU-CHEK ACTIVE TEST SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 5, 2001 after a review of 135 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K012324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date December 05, 2001
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
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 181
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K012324.
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
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