ReliOn Premier Classic Blood Glucose Monitoring System

K192220 · I-Sens, Inc. · NBW · Dec 13, 2019 · Clinical Chemistry

Device Facts

• Record ID: K192220
• Device Name: ReliOn Premier Classic Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh, and calf. Alternate site testing should be used only during steady-state blood glucose conditions. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Device Story

ReliOn™ Premier Classic Blood Glucose Monitoring System comprises a digital meter and disposable test strips. Device measures glucose concentration in fresh capillary whole blood samples via electrochemical sensing. Intended for home use by individuals with diabetes for self-monitoring of blood glucose levels. User applies blood sample to test strip inserted into meter; meter performs quantitative analysis and displays glucose concentration on integrated screen. Results assist patients in managing diabetes control. System designed for single-patient use; not for neonates or diagnostic screening.

Clinical Evidence

Bench testing only. Disinfection efficacy studies demonstrated complete inactivation of Hepatitis B Virus (HBV) using Clorox Germicidal Wipes. Robustness studies confirmed no change in performance or external materials after 260 cleaning and disinfection cycles, representing 5 years of single-patient use.

Technological Characteristics

Electrochemical glucose test system; consists of a handheld meter and disposable test strips. Operates via in vitro diagnostic measurement of capillary whole blood. Designed for single-patient use.

Indications for Use

Indicated for single patient home use for the monitoring of blood glucose levels.

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.

Submission Summary (Full Text)

{0}

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K192220

B Applicant
i-SENS, Inc.

C Proprietary and Established Names
ReliOn™ Premier Classic 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 Voice Blood Glucose Monitoring System (K121133). (For a preamendments device, a statement to this effect has been provided.)

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).

K192220 - Page 1 of 2

{1}

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. These modifications were as follows:

- Change of device color from white to black and start button symbol from S to ①.
- Replacement of the voice function with a beeping sound
- Change of device system name from CareSens N Voice Blood Glucose Monitoring System to ReliOn™ Premier Classic Blood Glucose Monitoring System

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

4. 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.

ReliOn™ Premier Blood Glucose Blood Glucose Monitoring System is intended for single patient home use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial laboratory testing services demonstrating complete inactivation of hepatitis B Virus (HBV) with Clorox Germicidal Wipe (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles representing 5 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures and found to be acceptable.

K192220 - Page 2 of 2