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 Description

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

AI/ML Overview

The provided text describes the GLUCOCARD® W onyx Blood Glucose Monitoring System but does not contain information about acceptance criteria or specific study results demonstrating that the device meets those criteria.

The document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria and results. While it lists various device features and compares them to the predicate device, it does not include any quantitative performance data, sample sizes for testing, ground truth establishment, or details about comparative effectiveness studies.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for test sets.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details or effect size.
Standalone performance details.
Type of ground truth used (beyond implying plasma reference for glucose levels).
Sample size for the training set.
How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence by highlighting design and functional similarities to the predicate device (GLUCOCARD® W Blood Glucose Monitoring System) and noting minor differences such as the addition of Bluetooth communication and changes in physical dimensions. It states that both devices "Have the same performance, measurement range, use environment and calibration functions," implying that the performance of the proposed device is expected to be the same as the predicate, which would have undergone performance testing at the time of its own clearance (K170064). However, the details of that performance testing are not included in this summary.

Summary

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

1. Administrative Information

Applicant's Nameand Address	ARKRAY Factory, Inc.1480 Koji, Konan-choKoka-shi, Shiga 520-3306 JapanEstablishment Registration # 3003422726
Contact Person	Dhwani ThakkarAssociate Regulatory Affairs Project Manager
Phone	952-746-2646
Email	thakkard@arkrayusa.com
Date Prepared	January 31, 2019

2. Device Information

Trade Name	GLUCOCARD® W onyx Blood Glucose MonitoringSystem
Classification Name	System, Test, Blood Glucose, Over The Counter
Common Name	Blood Glucose Monitoring System
Product Code	NBW
Classification Panel	75 – Clinical Chemistry
DeviceClassification	21 CFR § 862.1345

3. Predicate Device Information

Predicate Device Name	Predicate Device510(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.

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.

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/CHARACTERISTIC	PREDICATE	PROPOSED	COMPARISON
Blood Glucose Monitoring System
510(k) Number	K170064	K183306	N/A
COMPONENT/CHARACTERISTIC	PREDICATE	PROPOSED	COMPARISON
Monitoring System	GLUCOCARD® WBlood GlucoseMonitoring System	GLUCOCARD® Wonyx Blood GlucoseMonitoring System	N/ASame exceptBlood Glucose
Intended Use andIndications for Use	The GLUCOCARD® WBlood GlucoseMonitoring System iscomprised ofGLUCOCARD® WBlood Glucose Meter,GLUCOCARD® WBlood Glucose TestStrips and Assure®Control—ControlSolution.The GLUCOCARD® WBlood GlucoseMonitoring System isintended for use in thequantitativemeasurement of glucosein fresh capillary wholeblood samples drawnfrom the fingertip orpalm. Testing is doneoutside the body (invitro diagnostic use). Itis intended for use athome by persons withdiabetes, as an aid inmonitoring theeffectiveness of adiabetes controlprogram.	The GLUCOCARD®W onyx BloodGlucose MonitoringSystem is comprisedof GLUCOCARD® Wonyx Blood GlucoseMeter andGLUCOCARD® WBlood Glucose TestStrips.The GLUCOCARD®W onyx BloodGlucose MonitoringSystem is intended foruse in the quantitativemeasurement ofglucose in freshcapillary whole bloodsamples drawn fromthe fingertip or palm.Testing is doneoutside the body (invitro diagnostic use).It is intended for use athome by persons withdiabetes, as an aid inmonitoring theeffectiveness of adiabetes controlprogram.The GLUCOCARD®W onyx BloodGlucose MonitoringSystem is intended tobe used by a singleperson and should not	Meter andSystem tradenames wereupdated
COMPONENT/CHARACTERISTIC	PREDICATE	PROPOSED	COMPARISON
	The GLUCOCARD® WBlood GlucoseMonitoring System isintended to be used by asingle person and shouldnot be shared. Thissystem is not for use indiagnosis or screeningof diabetes mellitus, norfor neonatal use.Alternative site testingshould be done onlyduring steady-state times(when glucose is notchanging rapidly).	be shared. This systemis not for use indiagnosis or screeningof diabetes mellitus,nor for neonatal use.Alternative site testingshould be done onlyduring steady-statetimes (when glucose isnot changing rapidly).
Measurement Method	Amperometric	Amperometric	Same
Result Range	20 to 600 mg/dL	20 to 600 mg/dL	Same
Sample Type	Fresh Capillary WholeBlood*	Fresh Capillary WholeBlood*	Same
Calibration Reference	Plasma referenced	Plasma referenced	Same
Sample Application	Apply blood to end,capillary fill	Apply blood to end,capillary fill	Same
Blood Source	Fingertip, palm	Fingertip, palm	Same
Calibration Curve	Automatic codedcalibration	Automatic codedcalibration	Same
OperatingTemperatureRange	46°F to 104°F8°C to 40°C	46°F to 104°F8°C to 40°C	Same
TemperatureCompensation	Automaticcompensation usingbuilt-in thermosensor	Automaticcompensation usingbuilt-in thermosensor	Same
Operating HumidityRange	10% to 90% RelativeHumidity(No condensation)	10% to 90% RelativeHumidity(No condensation)	Same
Maximum Altitude	10,335 ft. (3,150 m)	10,335 ft. (3,150 m)	Same
COMPONENT/CHARACTERISTIC	PREDICATE	PROPOSED	COMPARISON
Hematocrit Range	20-70%	20-70%	Same
Hematocrit CorrectionFunction	Yes	Yes	Same
CommunicationFunction	Micro USB Port	Micro USB PortWirelesscommunicationfunction usingBluetooth 4.0	Same for USBPortcommunicationAddition ofwirelesscommunicationfunction toenable sendingresults to mobiledevices
Memory Capacity	500 Test Results	500 Test Results	Same
Minimum SampleVolume	0.5 µL	0.5 µL	Same
Test Time	7 Seconds	7 Seconds	Same
Power On	Insert Test Strip intoMeter	Insert Test Strip intoMeter	Same
Auto Power Off	Two Minutes after LastUserOperation (Five MinuteswhenWaiting for BloodApplication)	Two Minutes afterLast UserOperation (FiveMinutes whenWaiting for BloodApplication)	Same
Sample AutoDetectionFunction	Automatically Detects ifa Sample isWhole Blood or ControlSolution	Automatically Detectsif a Sample isWhole Blood orControl Solution	Same
Average Calculations	7, 14, 30, 60, 90 days	7, 14, 30, 60, 90 days	Same
Pre-set flag for Low orHigh Blood Sugar	Yes – Hi and Lo flagsset at >600 mg/dL and <20mg/dL, respectively	Yes – Hi and Lo flagsset at >600 mg/dL and< 20mg/dL,respectively	Same
User set indicator forhypoglycemia	Yes	Yes	Same
COMPONENT/CHARACTERISTIC	PREDICATE	PROPOSED	COMPARISON
User set indicator forhyperglycemia	No	Yes	Addition of auser-sethyperglycemiaindicator forresults over adetermined value(with input fromuser's healthcareprovider)
User set flags forresults	Before-MealsAfter-Meals	Before-MealsAfter-MealsBefore Go to Bed	Same formealtime resultsflagsAddition of auser-set BeforeGo To Bed Flagfor results takenbefore bedtime
Validated CleaningandDisinfectionInstructions	Yes	Yes	Same
Buttons and Function	Three Button- Front ofMeter	Three Button - LeftSide of Meter	Same number ofbuttonsChange inlocation,orientation andmaterial due toredesign ofmeter resultingfrom batterychange due toBluetoothmodule addition
COMPONENT/CHARACTERISTIC	PREDICATE	PROPOSED	COMPARISON
Dimensions	84 mm x 50 mm x 17.6mm	94 mm x 57 mm x18.5 mm	Largerdimension due tochange incomponents(battery)resulting fromBluetoothmodule addition
Weight	47 g	70 g	Heavier due tochange incomponents(battery) neededfor Bluetoothmodule addition
Batteries	1 x 3-volt lithiumbattery (CR2032)	3-volt LR03/2 x 1.5-volt AAA	Change inbattery typeneeded forBluetoothmodule addition
Display	Segment display	Negative segmentdisplay	Change to whitelettering onblackbackground forease of reading
Display Backlight	No	Yes	Addition ofbacklight todisplay to aid inreading
Sensor Port Light	No	Yes	Addition of lightto sensor port toaid in insertingtest strip
Test Strips	GLUCOCARD® WBlood Glucose TestStrips	GLUCOCARD® WBlood Glucose TestStrips	Same
Control Solution	Assure® Control—Control Solution	Assure® Control-Control Solution	Same

Table 1: Side-by-Side Comparison, Predicate Device vs. Proposed Device

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*Although whole blood samples are used for measurement, displayed results are equivalent to plasma glucose levels.

7. Previous FDA Submissions and Communications Regarding This Device

There have not been any previous FDA communications nor submissions regarding the proposed device.

8. Substantial Equivalence Conclusion

The GLUCOCARD® W onyx Blood Glucose Monitoring System has the following similarities to the GLUCOCARD W Blood Glucose Monitoring System.

Both the predicate GLUCOCARD® W and GLUCOCARD® W onyx Blood Glucose Monitoring Systems:

· Have the same intended use and indications for use
· Use the same operating technology
Use the same test strips and control solution
· Have the same performance, measurement range, use environment and calibration functions
Have the same shelf life

In summary, the GLUCOCARD® W onyx Blood Glucose Monitoring System is substantially equivalent to the predicate GLUCOCARD® W Blood Glucose Monitoring System based on the above comparisons.

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April 10, 2019

ARKRAY Factory, Inc. Dhwani Thakkar Associate Regulatory Affairs Project Manager 5182 West 76th Street Edina, MN 55439

Re: K183306

Trade/Device Name: GLUCOCARD® W onyx Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 8, 2019 Received: March 11, 2019

Dear Dhwani Thakkar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183306

Device Name

GLUCOCARD® W onyx Blood Glucose Monitoring System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.