Cleared Special

K032552 - ACCU-CHEK ADVANTAGE SYSTEM

K032552 is an FDA 510(k) clearance for ACCU-CHEK ADVANTAGE SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 24-day FDA review.

K032552 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
24d
Days
Class 2
Risk

K032552 is an FDA 510(k) clearance for the ACCU-CHEK ADVANTAGE 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 September 12, 2003 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.

FDA 510(k) Submission Details - K032552

510(k) Number K032552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2003
Decision Date September 12, 2003
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.

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 510
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K032552.
BTG SMARTEST GLUCOSE TEST SYSTEM
K032029 · Bt Medical · Dec 2003
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EASYGLUCO, MODEL IGM0002
K031501 · American Healthcare, Inc. · Oct 2003
GLUCOLEADER VALUE
K023279 · Hmd Biomedical, Inc. · Aug 2003
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
K030703 · Home Diagnostics, Inc. · Jul 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · Medline Industries, Inc. · Jul 2003
K032552 · ACCU-CHEK ADVANTAGE SYSTEM
Download PDF FDA Summary Roche Diagnostics Cor…