CONTOUR® NEXT ONE Blood Glucose Monitoring System

K210687 · Ascensia Diabetes Care · NBW · Aug 11, 2021 · Clinical Chemistry

Device Facts

• Record ID: K210687
• Device Name: CONTOUR® NEXT ONE Blood Glucose Monitoring System
• Applicant: Ascensia Diabetes Care
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 11, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CONTOUR® NEXT ONE Blood Glucose Monitoring Systems is for single-patient use only.

Device Story

CONTOUR® NEXT ONE Blood Glucose Monitoring System; single-patient use; quantitative measurement of glucose in capillary whole blood; aids diabetes control monitoring. Device utilizes electrochemical biosensor technology to measure glucose levels from blood samples. System includes meter and test strips. Used by patients for self-monitoring of blood glucose. Modifications in K210687 limited to user guide format (color booklet to black and white pamphlet) and packaging configurations. Fundamental scientific technology remains unchanged from predicate. Disinfection efficacy validated for 5-year use cycle using Clorox® Germicidal Wipes.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed system performance met specifications. Usability testing conducted for the updated black and white pamphlet user guide to ensure ease of use by typical customers.

Technological Characteristics

Glucose test system; electrochemical sensing. Meter features 7-segment display, BLE connectivity, and two CR2032 coin cell batteries. Test strips utilize desiccated-lined foil packaging. Software facilitates wireless data transmission to mobile app. No changes to core sensing technology or meter hardware compared to predicate.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• CONTOUR® NEXT ONE Blood Glucose Monitoring System (K191286)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K210687

B Applicant

Ascensia Diabetes Care

C Proprietary and Established Names

CONTOUR® NEXT ONE Blood Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.): CONTOUR® NEXT ONE Blood Glucose Monitoring System, (k191286).

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for:

- Changed the User Guide from a color booklet format to a black and white pamphlet format in addition to minor formatting labeling changes to the user guide, quick reference guide and test strip insert.
- Modifications to the system component packaging configurations.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The CONTOUR® NEXT ONE Blood Glucose Monitoring Systems is for single-patient use only. Disinfection efficacy studies described for the predicate device using Clorox® Germicidal Wipes (EPA registration # 67619-12) demonstrated complete inactivation of live Hepatitis B Virus (HBV) on the materials of the meters. Studies described for the predicate devices also demonstrate that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles designed to simulate cleaning and disinfection to support 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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