ReliOn Premier BLU Blood Glucose Monitoring System

K230625 · I-Sens, Inc. · NBW · Aug 10, 2023 · Clinical Chemistry

Device Facts

• Record ID: K230625
• Device Name: ReliOn Premier BLU Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 10, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ReliOn Premier BLU Blood Glucose Monitoring System is intended for single patient use only.

Device Story

ReliOn Premier BLU is a blood glucose monitoring system consisting of a meter and test strips. It measures glucose in fresh capillary whole blood from fingertips. The device features Bluetooth Low Energy for wireless smartphone communication. A new target range indicator function allows users to set a target range with a healthcare professional; the meter displays results on a colored backlight (red, green, blue) to indicate if the result is below, within, or above the target. The device is intended for single-patient home use. Healthcare providers use the output to assist patients in monitoring diabetes control. The system is powered by two 3.0V lithium batteries.

Clinical Evidence

No clinical data. Performance was established through non-clinical verification and validation testing, including software function tests, power consumption, battery lifetime, memory, EMC, electrical safety, and a human factors study.

Technological Characteristics

Blood glucose meter with Bluetooth Low Energy. Features a colored backlight LCD (red, green, blue) for target range indication. Powered by two 3.0V CR2032 lithium batteries. Includes C-Clips for PCB connection. Measurement range: 20-600 mg/dL. Sample size: 0.5 µL. Test time: 5 seconds. Memory: 1,000 results.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. Intended for use by people with diabetes at home as an aid to monitor 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

• CareSens N Premier BT Blood Glucose Monitoring System (K170614)

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

K230625

B Applicant

i-SENS, Inc.

C Proprietary and Established Names

ReliOn Premier BLU 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: CareSens N Premier BT Blood Glucose Monitoring System, k170614
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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- The addition of a target glucose range function with associated colored meter display backlights.
- The device system name was changed from CareSens N Premier BT Blood Glucose Monitoring System to ReliOn Premier BLU 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 ReliOn Premier BLU Blood Glucose Monitoring System is intended for single patient use only. Disinfection efficacy studies were previously performed on the exterior meter materials (K170614) by an outside testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant Clorox Germicidal Wipes (EPA Reg. No.: 67619-12). A robustness study was also previously performed by the sponsor demonstrating that there was no change in performance or in external materials of the meter after 260 cleaning and disinfection cycles 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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