← Product Code [NBW](/productcode/NBW) · K260689

# CVS Advanced PLUS Blood Glucose Monitoring System (K260689)

_I-Sens, Inc. · NBW · Oct 2, 2026 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K260689

## Device Facts

- **Applicant:** I-Sens, Inc.
- **Product Code:** [NBW](/productcode/NBW.md)
- **Decision Date:** Oct 2, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The device system is intended for single-patient use only.

## Device Story

CVS™ Advanced PLUS Blood Glucose Monitoring System is an in vitro diagnostic device for measuring capillary whole blood glucose. It utilizes electrochemical biosensor technology via test strips to provide quantitative glucose readings. Operated by patients for self-monitoring, the device displays results on an LCD screen. Modifications from the predicate include physical design changes (meter size, color, LCD size, button shape), addition of a test strip ejector, transition to USB Type-C port, addition of an LCD backlight, power supply change to dual 3.0V lithium batteries, and removal of Bluetooth functionality. The device is intended for single-patient use; validated for 5 years of use with Clorox Healthcare Bleach Germicidal Wipes for disinfection.

## Clinical Evidence

Bench testing only. Includes disinfection efficacy studies demonstrating complete inactivation of HBV using Clorox Healthcare Bleach Germicidal Wipes and a robustness study confirming no performance degradation after 260 cleaning/disinfection cycles, supporting a 5-year service life.

## Technological Characteristics

Electrochemical glucose biosensor system. Powered by two 3.0V lithium batteries. Features USB Type-C connectivity, LCD display with backlight, and test strip ejector mechanism. External materials validated for 5-year durability and disinfection with EPA-registered bleach wipes.

## Regulatory 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

- CareSens S Fit BT Blood Glucose Monitoring System ([K193590](/device/K193590.md))

## 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

K260689

B Applicant

i-Sens, Inc.

C Proprietary and Established Names

CVS™ Advanced PLUS 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: The CareSens S Fit BT Blood Glucose Monitoring System, k193590.
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).
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:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Change in the glucose target range indicators from LCD icons to an arrow pointing to indicator colors added to the meter housing.
- Changes to the meter size, meter color, LCD size, and button shape.
- Addition of a test strip ejector button.
- Change from a UART port to a USB Type-C port.
- Addition of a backlight to the LCD display.
- Change from one to two 3.0V lithium batteries.
- Removal of the Bluetooth communication function.
- The device system name was changed from CareSens S Fit BT Blood Glucose Monitoring System to CVS™ Advanced PLUS Blood Glucose Monitoring System.

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 device system is intended for single-patient use only. Disinfection efficacy studies were performed on the external materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Healthcare Bleach Germicidal Wipes (EPA Registration #67619-12). A robustness study was also conducted by the sponsor demonstrating that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles using the Clorox Healthcare Bleach Germicidal Wipes. The robustness studies were designed to support 5 years of single-patient device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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**Source:** [https://fda-staging.innolitics.com/device/K260689](https://fda-staging.innolitics.com/device/K260689)

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