GLUCOCARD W Blood Glucose Monitoring System

K170064 · Arkray Factory, Inc. · NBW · Aug 16, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170064
• Device Name: GLUCOCARD W Blood Glucose Monitoring System
• Applicant: Arkray Factory, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOCARD W Blood Glucose Monitoring System is comprised of GLUCOCARD W Blood Glucose Meter, GLUCOCARD W Blood Glucose Test Strips and Assure® Control–Control Solution. The GLUCOCARD W 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 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 disposable test strips and battery-powered meter; utilizes biosensor technology with glucose oxidase enzyme. Blood sample applied to strip; electrochemical reaction produces current proportional to glucose concentration; meter calculates and displays result. Used at home by patients with diabetes for self-monitoring. Provides quantitative results to aid in diabetes control program management. Includes short sample detection and automatic calibration coding. Data output allows patient to track glucose levels; helps inform diabetes management decisions. Single-patient use only; requires cleaning/disinfection.

Clinical Evidence

Clinical study with 300 lay users at 3 sites. Participants performed fingerstick (n=300) and palm (n=240) testing. Results compared to YSI 2300 laboratory analyzer. Fingerstick: 99.7% of results within ±20% of lab values. Palm: 99.2% within ±20%. Accuracy at extreme glucose values (n=100) showed 100% within ±15 mg/dL for concentrations ≤80 mg/dL and 100% within ±20% for concentrations ≥250 mg/dL. Bench testing included precision, linearity, interference, hematocrit, altitude, and temperature/humidity studies.

Technological Characteristics

Amperometric electrochemical glucose monitoring system. Uses glucose oxidase enzyme. Dimensions: 84x50x17.6 mm; Weight: 47g. Battery-powered. Connectivity: micro-USB port for PC data transfer. Hematocrit correction function included. Operating range: 8°C to 40°C, 10-90% RH. Automatic coded calibration via test strip.

Indications for Use

Indicated for persons with diabetes for quantitative measurement of glucose in fresh capillary whole blood from fingertip or palm as an aid in monitoring diabetes control. Not for diagnosis or screening of diabetes, not for neonatal use, and not for critically ill patients.

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® Vital™ Blood Glucose Monitoring System (k091102)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ARKRAY FACTORY, INC. WENDY KIVENS REGULATORY AFFAIRS PROJECT MANAGER 5182 WEST 76TH STREET EDINA MN 55439

Re: K170064

Trade/Device Name: GLUCOCARD W Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: July 7, 2017 Received: July 10, 2017

Dear Dr. Wendy Kivens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## 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 | Wendy J. Kivens, Ph.D., RAC (US)<br>Regulatory Affairs Project Manager |
| Phone | 952-646-3142 |
| Fax | 952-646-3230 |
| Email | [e-mail] |
| Date Prepared | August 7, 2017 |

# 2. Device Information

#### Device

| Trade Name | GLUCOCARD® W Blood Glucose Monitoring 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 |
| 510(k) Number | K170064 |

# 3. Predicate Device Information

| Predicate Device Name | Predicate Device<br>510(k) Number |
|---------------------------------------------------|-----------------------------------|
| GLUCOCARD® Vital™ Blood Glucose Monitoring System | K091102 |

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# 4. Device Description

The GLUCOCARD® W Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The GLUCOCARD® W Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W 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 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 your glucose level.

## 5. Indications for Use

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

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

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### Similarities and Differences Table

| COMPONENT/<br>CHARACTERISTIC | PROPOSED | PREDICATE |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Glucose Monitoring System | | |
| 510(k) Number | K170064 | K091102 |
| Monitoring System | GLUCOCARD® W Blood Glucose<br>Monitoring System | GLUCOCARD® VitalTM Blood<br>Glucose Monitoring System |
| Intended Use and<br>Indications for Use | The GLUCOCARD W Blood<br>Glucose Monitoring System is<br>comprised of GLUCOCARD W<br>Blood Glucose Meter and<br>GLUCOCARD W Blood Glucose<br>Test Strip.<br>The GLUCOCARD W Blood<br>Glucose Monitoring System is<br>intended for use in the quantitative<br>measurement of glucose in fresh<br>capillary whole blood samples<br>drawn from the fingertip or palm.<br>Testing is done outside the body ( <i>in<br/>vitro</i> diagnostic use). It is intended<br>for use at home by persons with<br>diabetes, as an aid in monitoring<br>the effectiveness of a diabetes<br>control program.<br>The GLUCOCARD W Blood<br>Glucose Monitoring System is<br>intended to be used by a single<br>person and should not be shared.<br>This system is not for use in<br>diagnosis or screening of diabetes<br>mellitus, nor for neonatal use.<br>Alternative site testing should be<br>done only during steady-state times<br>(when glucose is not changing<br>rapidly). | The GLUCOCARD® VitalTM<br>Blood Glucose Monitoring<br>System is intended for the<br>quantitative measurement of<br>glucose in fresh capillary whole<br>blood samples drawn from the<br>fingertips and palms. Testing is<br>done outside the body ( <i>In Vitro</i><br>diagnostic use). It is indicated for<br>use at home (over the counter<br>[OTC]) by persons with diabetes,<br>or in clinical settings by<br>healthcare professionals, as an aid<br>to monitor the effectiveness of<br>diabetes control.<br>GLUCOCARD® VitalTM test<br>strips are intended for the<br>quantitative measurement of<br>glucose in fresh capillary whole<br>blood samples drawn from the<br>fingertips and palms when used<br>with the GLUCOCARD® VitalTM<br>Blood Glucose Meter. Testing is<br>done outside the body ( <i>In Vitro</i><br>diagnostic use). They are<br>indicated for use in home (over<br>the counter [OTC]) by persons<br>with diabetes, or in clinical<br>settings by healthcare<br>professionals, as an aid to monitor<br>the effectiveness of diabetes<br>control. |
| Measurement Method | Amperometric | Amperometric |
| Result Range | 20 to 600 mg/dL | 20 to 600 mg/dL |
| COMPONENT/<br>CHARACTERISTIC | PROPOSED | PREDICATE |
| Sample Type | Fresh Capillary Whole Blood¹ | Fresh Capillary Whole Blood¹ |
| Calibration Reference | Plasma referenced | Plasma referenced |
| Sample Application | Apply blood to end, capillary fill | Apply blood to end, capillary fill |
| Blood Source | Fingertip, palm | Fingertip, palm |
| Calibration Curve | Automatic coded calibration | Automatic coded calibration |
| Operating Temperature<br>Range | 46°F to 104°F<br>8°C to 40°C | 50°F to 104°F<br>10°C to 40°C |
| Temperature Compensation | Automatic compensation using<br>built-in thermosensor | Automatic compensation using<br>built-in thermosensor |
| Operating Humidity Range | 10% to 90% Relative Humidity<br>(No condensation) | 20% to 80% Relative Humidity<br>(No condensation) |
| Maximum Altitude | 10,335 ft. (3,150 m) | 10,000 ft. (3,048 m) |
| Hematocrit Range | 20-70% | 33-52% |
| Hematocrit Correction<br>Function | Yes | No |
| Communication Function | Yes - micro USB Port | Yes – 2.5 mm jack PC Interface<br>Port |
| Memory Capacity | 500 Test Results | 250 Test Results |
| Minimum Sample Volume | 0.5 µL | 0.5 µL |
| Test Time | 7 Seconds | 7 Seconds |
| Power On | Insert Test Strip into Meter | Insert Test Strip into Meter |
| Auto Power Off | Two minutes after last User<br>operation (five minutes when<br>waiting for blood application) | Two minutes after last user action |
| Sample Auto Detection<br>Function | Automatically detects if a sample is<br>whole blood or control solution | Cannot detect differences between<br>whole blood and control solution |
| Average Calculations | 7, 14, 30, 60, 90 days | 14, 30 days |
| Flag for Low Blood Sugar | Yes | No |
| COMPONENT/<br>CHARACTERISTIC | PROPOSED | PREDICATE |
| Validated Cleaning and<br>Disinfection Instructions | Yes | No |
| Buttons and Function | Three Button | Three Button |
| Dimensions | 84 mm x 50 mm x 17.6 mm | 80 mm x 46 mm x 16 mm |
| Weight | 47 g | 39 g |
| Batteries | 1 x 3-volt lithium battery (CR2032) | 1 x 3-volt lithium battery<br>(CR2032)…