GLUCOCARD® W onyx Blood Glucose Monitoring System

K183306 · Arkray Factory, Inc. · NBW · Apr 10, 2019 · Clinical Chemistry

Device Facts

• Record ID: K183306
• Device Name: GLUCOCARD® W onyx Blood Glucose Monitoring System
• Applicant: Arkray Factory, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 10, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOCARD® W onyx Blood Glucose Monitoring System is comprised of GLUCOCARD® W onyx Blood Glucose Meter and disposable GLUCOCARD® W Blood Glucose Test Strips. The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program. The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor technology using glucose oxidase enzyme. Input: capillary blood sample on disposable test strip; Output: plasma-equivalent glucose concentration displayed on meter. Used at home by patients with diabetes. Features: auto-coding for lot sensitivity, temperature correction, hematocrit correction, sample auto-detection (blood vs. control), and sensor insertion/removal detection. Data transmission via USB or Bluetooth to mobile devices. Output aids patients in monitoring diabetes control program effectiveness. Device redesign from predicate includes Bluetooth module, larger form factor, negative segment display with backlight, and sensor port light.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics.

Technological Characteristics

Electrochemical glucose monitoring. Power: 2 x 1.5V AAA batteries. Connectivity: Bluetooth 4.0. Display: Backlit, white font on black background. Features: Test strip port light, user-settable flags. Materials validated for 160 cleaning/disinfection cycles.

Indications for Use

Indicated for single patient home use for blood glucose monitoring.

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

• GLUCOCARD® W Blood Glucose Monitoring System (K170064)

Submission Summary (Full Text)

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# 510(k) Summary: K183306 GLUCOCARD® W onyx Blood Glucose Monitoring System

## 1. Administrative Information

| Applicant's Name<br>and Address | ARKRAY Factory, Inc.<br>1480 Koji, Konan-cho<br>Koka-shi, Shiga 520-3306 Japan<br>Establishment Registration # 3003422726 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Dhwani Thakkar<br>Associate Regulatory Affairs Project Manager |
| Phone | 952-746-2646 |
| Email | [e-mail] |
| Date Prepared | January 31, 2019 |

# 2. Device Information

| Trade Name | GLUCOCARD® W onyx Blood Glucose Monitoring<br>System |
|--------------------------|------------------------------------------------------|
| Classification Name | System, Test, Blood Glucose, Over The Counter |
| Common Name | Blood Glucose Monitoring System |
| Product Code | NBW |
| Classification Panel | 75 – Clinical Chemistry |
| Device<br>Classification | 21 CFR § 862.1345 |

## 3. Predicate Device Information

| Predicate Device Name | Predicate Device<br>510(k) Number |
|------------------------------------------------------|-----------------------------------|
| GLUCOCARD® W Blood Glucose Monitoring System | K170064 |
| Including GLUCOCARD® W Blood Glucose Test Strips and | |
| Assure® Control—Control Solutions | |

## 4. Device Description

The GLUCOCARD® W onyx Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The

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GLUCOCARD® W onyx Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W onyx Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W onyx Blood Glucose Monitoring System utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Although capillary blood samples are used for measurement, the results displayed on the GLUCOCARD® W onyx Blood Glucose Monitoring System are equivalent to plasma glucose levels.

The biosensor (GLUCOCARD® W Blood Glucose Test Strips) operates on the electrochemical detection of the reaction of glucose with the enzyme glucose oxidase.

Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the glucose level in the blood.

## 4.1 Device Features

The GLUCOCARD® W onyx Blood Glucose Monitoring System has the following device features.

- . Data Transmission: Device has the capability to communicate with an external PC using a commercially available USB cable or the added capability to communicate with mobile devices via Bluetooth wireless technology.
- . Enhanced Robustness and Ease of Use: Features such as the below are incorporated to enhance robustness and also for ease of use
- a) Auto coding function: Reads information recorded in the sensor and automatically corrects sensor sensitivity per manufacturing lot.
- b) Temperature correction function: Reads ambient temperature and corrects impact of temperature on measurement results.
- c) Hematocrit correction function: Obtains hematocrit value from calibration curve for peak top and hematocrit values to correct hematocrit impact on measurement results.
- d) Sample auto detection function: Automatically detects if a sample is whole blood or control solution.
- e) Sensor insertion/detection function: Detects sensor insertion automatically and turns the power on.
- f) Sensor removal detection function: Automatically detects sensor removal and turns the power off.

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- g) Flag setting function: Users can manually set flags to measurement results to help categorize and identify results.
- h) Davlight Savings Time feature. Users can set the meter clock to automatically change the time to Daylight Savings Time as desired.

### 5. Indications for Use

The GLUCOCARD® W onyx Blood Glucose Monitoring System is comprised of GLUCOCARD® W onyx Blood Glucose Meter and disposable GLUCOCARD® W Blood Glucose Test Strips.

The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program.

The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

## 6. Substantial Equivalence Information

The GLUCOCARD® W onyx Blood Glucose Monitoring System is substantially equivalent to the GLUCOCARD® W Blood Glucose Monitoring System. Below is a table that provides a comparison between the GLUCOCARD® W onyx Blood Glucose Monitoring System and its predicate device.

| COMPONENT/<br>CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Glucose Monitoring System | | | |
| 510(k) Number | K170064 | K183306 | N/A |
| COMPONENT/<br>CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| Monitoring System | GLUCOCARD® W<br>Blood Glucose<br>Monitoring System | GLUCOCARD® W<br>onyx Blood Glucose<br>Monitoring System | N/A<br>Same except<br>Blood Glucose |
| Intended Use and<br>Indications for Use | The GLUCOCARD® W<br>Blood Glucose<br>Monitoring System is<br>comprised of<br>GLUCOCARD® W<br>Blood Glucose Meter,<br>GLUCOCARD® W<br>Blood Glucose Test<br>Strips and Assure®<br>Control—Control<br>Solution.<br>The GLUCOCARD® W<br>Blood Glucose<br>Monitoring System is<br>intended for use in the<br>quantitative<br>measurement of glucose<br>in fresh capillary whole<br>blood samples drawn<br>from the fingertip or<br>palm. Testing is done<br>outside the body (in<br>vitro diagnostic use). It<br>is intended for use at<br>home by persons with<br>diabetes, as an aid in<br>monitoring the<br>effectiveness of a<br>diabetes control<br>program. | The GLUCOCARD®<br>W onyx Blood<br>Glucose Monitoring<br>System is comprised<br>of GLUCOCARD® W<br>onyx Blood Glucose<br>Meter and<br>GLUCOCARD® W<br>Blood Glucose Test<br>Strips.<br>The GLUCOCARD®<br>W onyx Blood<br>Glucose Monitoring<br>System is intended for<br>use in the quantitative<br>measurement of<br>glucose in fresh<br>capillary whole blood<br>samples drawn from<br>the fingertip or palm.<br>Testing is done<br>outside the body (in<br>vitro diagnostic use).<br>It is intended for use at<br>home by persons with<br>diabetes, as an aid in<br>monitoring the<br>effectiveness of a<br>diabetes control<br>program.<br>The GLUCOCARD®<br>W onyx Blood<br>Glucose Monitoring<br>System is intended to<br>be used by a single<br>person and should not | Meter and<br>System trade<br>names were<br>updated |
| COMPONENT/<br>CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| | The GLUCOCARD® W<br>Blood Glucose<br>Monitoring System is<br>intended to be used by a<br>single person and should<br>not be shared. This<br>system is not for use in<br>diagnosis or screening<br>of diabetes mellitus, nor<br>for neonatal use.<br>Alternative site testing<br>should be done only<br>during steady-state times<br>(when glucose is not<br>changing rapidly). | be shared. This system<br>is not for use in<br>diagnosis or screening<br>of diabetes mellitus,<br>nor for neonatal use.<br>Alternative site testing<br>should be done only<br>during steady-state<br>times (when glucose is<br>not changing rapidly). | |
| Measurement Method | Amperometric | Amperometric | Same |
| Result Range | 20 to 600 mg/dL | 20 to 600 mg/dL | Same |
| Sample Type | Fresh Capillary Whole<br>Blood* | Fresh Capillary Whole<br>Blood* | Same |
| Calibration Reference | Plasma referenced | Plasma referenced | Same |
| Sample Application | Apply blood to end,<br>capillary fill | Apply blood to end,<br>capillary fill | Same |
| Blood Source | Fingertip, palm | Fingertip, palm | Same |
| Calibration Curve | Automatic coded<br>calibration | Automatic coded<br>calibration | Same |
| Operating<br>Temperature<br>Range | 46°F to 104°F<br>8°C to 40°C | 46°F to 104°F<br>8°C to 40°C | Same |
| Temperature<br>Compensation | Automatic<br>compensation using<br>built-in thermosensor | Automatic<br>compensation using<br>built-in thermosensor | Same |
| Operating Humidity<br>Range | 10% to 90% Relative<br>Humidity<br>(No condensation) | 10% to 90% Relative<br>Humidity<br>(No condensation) | Same |
| Maximum Altitude | 10,335 ft. (3,150 m) | 10,335 ft. (3,150 m) | Same |
| COMPONENT/<br>CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| Hematocrit Range | 20-70% | 20-70% | Same |
| Hematocrit Correction<br>Function | Yes | Yes | Same |
| Communication<br>Function | Micro USB Port | Micro USB Port<br>Wireless<br>communication<br>function using<br>Bluetooth 4.0 | Same for USB<br>Port<br>communication<br>Addition of<br>wireless<br>communication<br>function to<br>enable sending<br>results to mobile<br>devices |
| Memory Capacity | 500 Test Results | 500 Test Results | Same |
| Minimum Sample<br>Volume | 0.5 µL | 0.5 µL | Same |
| Test Time | 7 Seconds | 7 Seconds | Same |
| Power On | Insert Test Strip into<br>Meter | Insert Test Strip into<br>Meter | Same |
| Auto Power Off | Two Minutes after Last<br>User<br>Operation (Five Minutes<br>when<br>Waiting for Blood<br>Application) | Two Minutes after<br>Last User<br>Operation (Five<br>Minutes when<br>Waiting for Blood<br>Application) | Same |
| Sample Auto<br>Detection<br>Function | Automatically Detects if<br>a Sample is<br>Whole Blood or Control<br>Solution | Automatically Detects<br>if a Sample is<br>Whole Blood or<br>Control Solution | Same |
| Average Calculations | 7, 14, 30, 60, 90 days | 7, 14, 30, 60, 90 days | Same |
| Pre-set flag for Low or<br>High Blood Sugar | Yes – Hi and Lo flags<br>set at >600 mg/dL and <<br>20mg/dL, respectively | Yes – Hi and Lo flags<br>set at >600 mg/dL and<br>< 20mg/dL,<br>respectively | Same |
| User set indicator for<br>hypoglycemia | Yes | Yes | Same |
| COMPONENT/<br>CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| User set indicator for<br>hyperglycemia | No | Yes | Addition of a<br>user-set<br>hyperglycemia<br>indicator for<br>results over a<br>determined value<br>(with input from<br>user's healthcare<br>provider) |
| User set flags for<br>results | Before-Meals<br>After-Meals | Before-Meals<br>After-Meals<br>Before Go to Bed | Same for<br>mealtime results<br>flags<br>Addition of a<br>user-set Before<br>Go To Bed Flag<br>for results taken<br>before bedtime |
| Validated Cleaning<br>and<br>Disinfection<br>Instructions | Yes | Yes | Same |
| Buttons and Function | Three Button- Front of<br>Meter | Three Button - Left<br>Side of Meter | Same number of<br>buttons<br>Change in<br>location,<br>orientation and<br>material due to<br>redesign of<br>meter resulting<br>from battery<br>change due to<br>Bluetooth<br>module addition |
| COMPONENT/<br>CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| Dimensions | 84 mm x 50 mm x 17.6<br>mm | 94 mm x 57 mm x<br>18.5 mm | Larger<br>dimension due to<br>change in<br>components<br>(battery)<br>resulting from<br>Bluetooth<br>module addition |
| Weight | 47 g | 70 g | Heavier due to<br>change in<br>components<br>(battery) needed<br>for Bluetooth<br>module addition |
| Batteries | 1 x 3-volt lithium<br>battery (CR2032) | 3-volt LR03/2 x 1.5-<br>volt AAA | Change in<br>battery type<br>needed for<br>Bluetooth<br>module addition |
| Display | Segment display | Negative segment<br>display | Change to white<br>lettering on<br>black<br>background for<br>ease of reading |
| Display Backlight | No | Yes | Addition of<br>backlight to<br>display to aid in<br>reading |
| Sensor Port Light | No | Yes…