Cleared Special

K141867 - ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM

K141867 is an FDA 510(k) clearance for ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE M..., manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 236-day FDA review.

K141867 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
236d
Days
Class 2
Risk

K141867 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 3, 2015 after a review of 236 days - an extended review 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. 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.

FDA 510(k) Submission Details - K141867

510(k) Number K141867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2014
Decision Date March 03, 2015
Days to Decision 236 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
148d slower than avg
Panel avg: 88d · This submission: 236d
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 K141867.
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
K132663 · Alliance International Co., Ltd. · Apr 2015
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
K141914 · Ok Biotech Co., Ltd. · Apr 2015
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
K150052 · Nipro Diagnostics, Inc. · Mar 2015
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
K141862 · H2, Inc. · Dec 2014
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
K140371 · Abbott Diabetes Care, Inc. · Sep 2014
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
K141829 · Ceragem Medisys, Inc. · Sep 2014
K141867 · ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Roche Diagnostics