Cleared Traditional

K163159 - Dario Blood Glucose Monitoring System

K163159 is an FDA 510(k) clearance for Dario Blood Glucose Monitoring System, manufactured by Labstyle Innovations, Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K163159 · Labstyle Innovations, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
251d
Days
Class 2
Risk

K163159 is an FDA 510(k) clearance for the Dario Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Labstyle Innovations, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 19, 2017 after a review of 251 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 Labstyle Innovations, Ltd. devices

FDA 510(k) Submission Details - K163159

510(k) Number K163159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date July 19, 2017
Days to Decision 251 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
163d slower than avg
Panel avg: 88d · This submission: 251d
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.

Regulatory Consultant

Qualtra Consulting, Inc.
Tracey Wielinski

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.

Clinical Evidence

ClinicalTrials.gov
NCT02910674 Completed Interventional Industry-sponsored

Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

Dario Blood Glucose Monitoring System - Android Devices User Performance

102
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Single group
Eligibility All sexes · 13 Years+ · Healthy volunteers accepted
Sponsor LabStyle Innovations Ltd. (industry)
Started 2016-07-01 → Primary completion 2016-07-01 → Completed 2016-08-01
Primary outcome
Accuracy of Glucose Concentrations (%)
View full study on ClinicalTrials.gov

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 K163159.
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K162564 · Tianjin Empecs Medical Device Co., Ltd. · Jun 2017
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