Cleared Special

K131029 - ACCU-CHEK AVIVA PLUS TEST STRIP

K131029 is an FDA 510(k) clearance for ACCU-CHEK AVIVA PLUS TEST STRIP, manufactured by Roche Diagnostics Operations, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 119-day FDA review.

K131029 · Roche Diagnostics Operations, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
119d
Days
Class 2
Risk

K131029 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA PLUS TEST STRIP. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Roche Diagnostics Operations, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 119 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. 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. Standard predicate reliance. 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 Operations, Inc. devices

FDA 510(k) Submission Details - K131029

510(k) Number K131029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date August 09, 2013
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
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 423
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