(133 days)
Not Found
No
The description details a standard electrochemical biosensor technology for glucose measurement, with no mention of AI or ML algorithms for data processing, interpretation, or prediction.
No
The device is described as an "aid in monitoring the effectiveness of a diabetes control program" and "not for use in diagnosis or screening of diabetes mellitus." It measures glucose levels, which is a diagnostic/monitoring function, not a therapeutic one (i.e., it doesn't treat the condition).
No
The "Intended Use / Indications for Use" section explicitly states, "This system is not for use in diagnosis or screening of diabetes mellitus". It is intended for monitoring purposes by individuals already diagnosed with diabetes.
No
The device description explicitly states that the system is comprised of a "GLUCOCARD® W onyx Blood Glucose Meter" and "disposable GLUCOCARD® W Blood Glucose Test Strips," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "Testing is done outside the body (in vitro diagnostic use)."
Furthermore, the device description details how it measures glucose in blood samples using biosensor technology, which is a common method for in vitro diagnostic testing.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
NBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at home by persons with diabetes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image contains the word "arkray" in a sans-serif font. The letters are gray and the background is white. The word is enclosed in a rounded rectangle.
510(k) Summary: K183306 GLUCOCARD® W onyx Blood Glucose Monitoring System
1. Administrative Information
| Applicant's Name
and Address | ARKRAY Factory, Inc.
1480 Koji, Konan-cho
Koka-shi, Shiga 520-3306 Japan
Establishment Registration # 3003422726 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Dhwani Thakkar
Associate 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 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
Classification | 21 CFR § 862.1345 |
3. Predicate Device Information
| Predicate Device Name | Predicate Device
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
1
Image /page/1/Picture/1 description: The image features the word "arkray" in a rounded rectangular box. The text is in a sans-serif font and appears to be a light gray color. The background is white, providing a clean and simple contrast.
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.
2
Image /page/2/Picture/1 description: The image shows the word "arkray" in a simple, sans-serif font. The letters are gray and appear to be enclosed in a rounded rectangle. The overall design is clean and minimalist.
- 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/
| CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
|---|---|---|---|
| Blood Glucose Monitoring System | |||
| 510(k) Number | K170064 | K183306 | N/A |
| COMPONENT/ | |||
| CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| Monitoring System | GLUCOCARD® W | ||
| Blood Glucose | |||
| Monitoring System | GLUCOCARD® W | ||
| onyx Blood Glucose | |||
| Monitoring System | N/A | ||
| Same except | |||
| Blood Glucose | |||
| Intended Use and | |||
| Indications for 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 onyx Blood | |||
| Glucose Monitoring | |||
| System is comprised | |||
| of GLUCOCARD® W | |||
| onyx Blood Glucose | |||
| Meter and | |||
| 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 | Meter and | ||
| System trade | |||
| names were | |||
| updated | |||
| COMPONENT/ | |||
| CHARACTERISTIC | PREDICATE | PROPOSED | COMPARISON |
| 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). | 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). | |||
| Measurement Method | Amperometric | Amperometric | Same |
| Result Range | 20 to 600 mg/dL | 20 to 600 mg/dL | Same |
| Sample Type | Fresh Capillary Whole | ||
| Blood* | Fresh Capillary Whole | ||
| Blood* | 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 coded | ||
| calibration | Automatic coded | ||
| calibration | Same | ||
| Operating | |||
| Temperature | |||
| Range | 46°F to 104°F | ||
| 8°C to 40°C | 46°F to 104°F | ||
| 8°C to 40°C | Same | ||
| Temperature | |||
| Compensation | Automatic | ||
| compensation using | |||
| built-in thermosensor | Automatic | ||
| compensation using | |||
| built-in thermosensor | Same | ||
| Operating Humidity | |||
| Range | 10% to 90% Relative | ||
| Humidity | |||
| (No condensation) | 10% to 90% Relative | ||
| Humidity | |||
| (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 Correction | |||
| Function | Yes | Yes | Same |
| Communication | |||
| Function | Micro USB Port | Micro USB Port | |
| Wireless | |||
| communication | |||
| function using | |||
| Bluetooth 4.0 | Same for USB | ||
| Port | |||
| communication | |||
| Addition of | |||
| wireless | |||
| communication | |||
| function to | |||
| enable sending | |||
| results to mobile | |||
| devices | |||
| Memory Capacity | 500 Test Results | 500 Test Results | Same |
| Minimum Sample | |||
| Volume | 0.5 µL | 0.5 µL | Same |
| Test Time | 7 Seconds | 7 Seconds | Same |
| Power On | Insert Test Strip into | ||
| Meter | Insert Test Strip into | ||
| Meter | Same | ||
| Auto Power Off | Two Minutes after Last | ||
| User | |||
| Operation (Five Minutes | |||
| when | |||
| Waiting for Blood | |||
| Application) | Two Minutes after | ||
| Last User | |||
| Operation (Five | |||
| Minutes when | |||
| Waiting for Blood | |||
| Application) | Same | ||
| Sample Auto | |||
| Detection | |||
| Function | Automatically Detects if | ||
| a Sample is | |||
| Whole Blood or Control | |||
| Solution | Automatically Detects | ||
| if a Sample is | |||
| Whole Blood or | |||
| Control Solution | Same | ||
| Average Calculations | 7, 14, 30, 60, 90 days | 7, 14, 30, 60, 90 days | Same |
| Pre-set flag for Low or | |||
| High Blood Sugar | Yes – Hi and Lo flags | ||
| set at >600 mg/dL and 600 mg/dL and | |||
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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