Cleared Traditional

K160682 - CONTOUR NEXT ONE Blood Glucose Monitoring System

K160682 is an FDA 510(k) clearance for CONTOUR NEXT ONE Blood Glucose Monitori..., manufactured by Ascensia Diabetes Care. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K160682 · Ascensia Diabetes Care · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
252d
Days
Class 2
Risk

K160682 is an FDA 510(k) clearance for the CONTOUR NEXT ONE Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ascensia Diabetes Care (Mishawaka, US). The FDA issued a Cleared decision on November 17, 2016 after a review of 252 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 Ascensia Diabetes Care devices

FDA 510(k) Submission Details - K160682

510(k) Number K160682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2016
Decision Date November 17, 2016
Days to Decision 252 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
164d slower than avg
Panel avg: 88d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02390167 Completed Interventional Industry-sponsored

Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

User Performance of the ONYX NEXT Blood Glucose Monitoring System

376
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Timothy Bailey, MD, FACP
Sponsor Ascensia Diabetes Care (industry)
Started 2015-03-01 → Primary completion 2015-04-01
Primary outcome
Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Secondary outcome
Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
View full study on ClinicalTrials.gov

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

All 505
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K160682.
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
K161299 · Apex BioTechnology Corp. · Dec 2016
NoCoding1 Plus Blood Glucose Monitoring System
K160742 · I-Sens, Inc. · Dec 2016
One Drop Blood Glucose Monitoring System
K161834 · Agamatrix, Inc. · Nov 2016
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
K161738 · Taidoc Technology Corporation · Nov 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
K160365 · Infopia Co, Ltd. · Sep 2016
ACCU-CHEK Guide Blood Glucose Monitoring System
K160944 · Roche Diabetes Care, Inc. · Aug 2016