Cleared Traditional

OneTouch Verio Reflect Blood Glucose Monitoring System (K193475) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence.

K193475 · Lifescan Europe GmbH · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
60d
Days
Class 2
Risk

K193475 is an FDA 510(k) clearance for the OneTouch Verio Reflect Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Lifescan Europe GmbH (Zug, CH). The FDA issued a Cleared decision on February 14, 2020 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifescan Europe GmbH devices

Submission Details

510(k) Number K193475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date February 14, 2020
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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.

Clinical Evidence

ClinicalTrials.gov
NCT03851549 Unknown Interventional Industry-sponsored

A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.

360
Patients (est.)
4
Sites
Other
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Single group
Eligibility All sexes · 12 Years+
Principal investigator Kirsty Macleod
Sponsor LifeScan Scotland Ltd (industry)
Started 2019-03-12 → Primary completion 2019-04-19
Primary outcome
User Performance ( UP)
View full study on ClinicalTrials.gov

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

All 507
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