GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

K181273 · I-Sens, Inc. · NBW · Nov 1, 2018 · Clinical Chemistry

Device Facts

• Record ID: K181273
• Device Name: GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 1, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Express 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. The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Express Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Device Story

Handheld blood glucose monitoring system (BGMS) for home use by patients with diabetes. System components: meter, test strips, control solution. Input: fresh capillary whole blood sample applied to test strip. Principle: amperometric electrochemical reaction; glucose oxidase enzyme reacts with glucose to generate electrical current proportional to glucose concentration. Meter measures current; calculates and displays glucose level (mg/dL). Connex model includes Bluetooth connectivity; Express model includes audio output (English/Spanish). Used by patients for self-monitoring to assess diabetes control effectiveness. Output used by patients to track glucose trends; aids in diabetes management decisions. Single-patient use; requires cleaning/disinfection to prevent blood-borne pathogen spread.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance, functionality, and reliability. Disinfection studies using Clorox Germicidal Wipes demonstrated complete inactivation of HBV and confirmed that 260 cleaning/disinfection cycles (simulating 5 years of use) do not affect device performance or materials.

Technological Characteristics

Electrochemical glucose biosensor. Meter housing: Acryl. Display: Positive LCD. Data interface: Micro USB. Power: 2x 1.5V AAA alkaline batteries (Express) or CR2032 (Connex). Audio output: Talking feature (Express). Connectivity: Data transfer via USB. Sterilization: N/A (non-sterile home use device).

Indications for Use

Indicated for single patient home use for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm.

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

Submission Summary (Full Text)

{0}

SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k181273

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

The name and 510(k) number of the applicant’s previously cleared device. CareSens N Premier Blood Glucose Monitoring System, and CareSens N Premier BT Blood Glucose Monitoring System (k170614) (For a preamendments device, a statement to this effect has been provided.)

1. Applicant’s statement that the INDICATION/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).

2. 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:

The CareSens N Premier BT Blood Glucose Monitoring System was modified as follows to create the GLUCOCARD Shine Connex Blood Glucose Monitoring System:

- Change in meter material, from Polycarbonate to Acryl.
- Change in LCD display from a negative to a positive display.
- Change in data transfer port from a phone jack to a Micro USB port.

The CareSens N Premier Blood Glucose Monitoring System was modified as follows to create the GLUCOCARD Shine Express Blood Glucose Monitoring System:

- Addition of a talking feature.
- Change in meter material, from Polycarbonate to Acryl.
- Change in LCD display from a negative to a positive display.
- Change in data transfer port from a phone jack to a Micro USB port.
- Change in Power source from two 3.0V Lithium batteries (CR2032) to two 1.5 V AAA alkaline batteries.

3. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and specifications.

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 applicant’s description of the

{1}

particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant 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.

GLUCOCARD Shine Connex Blood Glucose Monitoring System and GLUCOCARD Shine Express Blood Glucose Monitoring System are 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.

2