Cleared Traditional

K151611 - OneTouch Ultra Plus Flex Blood Glucose Monitoring System

K151611 is an FDA 510(k) clearance for OneTouch Ultra Plus Flex Blood Glucose ..., manufactured by Lifescan Europe. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K151611 · Lifescan Europe · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
182d
Days
Class 2
Risk

K151611 is an FDA 510(k) clearance for the OneTouch Ultra Plus Flex Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Lifescan Europe (Zug, CH). The FDA issued a Cleared decision on December 14, 2015 after a review of 182 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifescan Europe devices

FDA 510(k) Submission Details - K151611

510(k) Number K151611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2015
Decision Date December 14, 2015
Days to Decision 182 days
Submission Type Traditional
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
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Lifescan Scotland, Ltd.
NIKI SKELLY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K151611.
Dario Blood Glucose Monitoring System
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Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · Abbott Laboratories · Dec 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
K150833 · Andon Health Co, Ltd. · Dec 2015
Gmate Origin Blood Glucose Monitoring System
K151658 · Philosys, Inc. · Dec 2015
Contour Next USB Blood Glucose Monitoring System
K150942 · Bayer Healthcare · Nov 2015