Cleared Traditional

K231679 - CONTOUR® PLUS BLUE Blood Glucose Monitoring System (FDA 510(k) Clearance)

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

K231679 · Ascensia Diabetes Care · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
259d
Days
Class 2
Risk

K231679 is an FDA 510(k) clearance for the CONTOUR® PLUS BLUE 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 (Valhalla, US). The FDA issued a Cleared decision on February 23, 2024 after a review of 259 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

Submission Details

510(k) Number K231679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2023
Decision Date February 23, 2024
Days to Decision 259 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
171d slower than avg
Panel avg: 88d · This submission: 259d
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.

Clinical Evidence

ClinicalTrials.gov
NCT04008836 Completed Interventional Industry-sponsored

User Performance of the Thunder Plus BGMS

User Performance of the T-Plus Blood Glucose Monitoring Systems

384
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Mark Christiansen, MD
Sponsor Ascensia Diabetes Care (industry)
Started 2019-06-10 → Primary completion 2019-07-31
Primary outcome
Number of Participants With Accurate BGMS Fingerstick Results
Secondary outcome
Number of Participants With Accurate BGMS Palm (AST) Results.
View full study on ClinicalTrials.gov

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

All 507
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