Cleared Special

K012210 - MODIFICATION TO ACCU-CHEK INFORM METER

K012210 is the FDA 510(k) clearance for MODIFICATION TO ACCU-CHEK INFORM METER by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 24-day FDA review.

K012210 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
24d
Days
Class 2
Risk

K012210 is an FDA 510(k) clearance for the MODIFICATION TO ACCU-CHEK INFORM METER. 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 August 9, 2001 after a review of 24 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 K012210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 09, 2001
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 K012210.
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · Roche Diagnostics Corp. · Dec 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · Medline Industries, Inc. · Sep 2001
GLUCOMETER DEX TEST SENSOR
K012205 · Bayer Corp. · Sep 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