Cleared Special

K022171 - ACCU-CHEK COMPACT SYSTEM

K022171 is the FDA 510(k) clearance for ACCU-CHEK COMPACT SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 20-day FDA review.

K022171 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
20d
Days
Class 2
Risk

K022171 is an FDA 510(k) clearance for the ACCU-CHEK COMPACT 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 July 23, 2002 after a review of 20 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K022171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date July 23, 2002
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K022171.
ASCENSIA DEX 2 DIABETES CARE SYSTEM
K023584 · Bayer Corp. · Nov 2002
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
K022581 · Becton, Dickinson & CO · Oct 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
K022182 · Abbott Laboratories · Sep 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · Roche Diagnostics Corp. · Jul 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · Roche Diagnostics Corp. · Jun 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · Roche Diagnostics Corp. · Jun 2002