(219 days)
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).
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.
The document describes the performance testing of the GLUCOCARD® W Blood Glucose Monitoring System, an in vitro diagnostic device. The acceptance criteria and supporting studies are detailed below, primarily focusing on the accuracy of blood glucose measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the accuracy of blood glucose measurements are derived from the 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. The reported device performance is based on the Finger-Stick Data Accuracy and Alternate Site (Palm) Data Accuracy studies.
| Criteria (Difference from True Blood Glucose Level) | Acceptance Criterion (FDA Guidance) | Reported Device Performance (Finger-stick) | Reported Device Performance (Alternate Site - Palm) |
|---|---|---|---|
| Within ± 5% | Not explicitly stated as a primary criterion for overall system accuracy in the provided text, but data is presented. | 63.7% (191/300) | 55.8% (134/240) |
| Within ± 10% | For glucose concentrations ≥ 100 mg/dL: ≥ 95% of results within ± 10%. For glucose concentrations < 100 mg/dL: ≥ 95% of results within ± 10 mg/dL. The document simplifies to "within ±X%" without specifying the concentration split for this table, so we use the overall percentage provided. | 92.7% (278/300) | 88.8% (213/240) |
| Within ± 15% | For glucose concentrations ≥ 100 mg/dL: ≥ 98% of results within ± 15%. For glucose concentrations < 100 mg/dL: ≥ 98% of results within ± 15 mg/dL. The document simplifies to "within ±X%" without specifying the concentration split for this table, so we use the overall percentage provided. | 99.0% (297/300) | 97.1% (233/240) |
| Within ± 20% | Not explicitly stated as a primary criterion for overall system accuracy beyond the 15% criterion, but data is presented. Implies acceptance if 98% meets 15% or 95% meets 10%. | 99.7% (299/300) | 99.2% (238/240) |
Accuracy at Extreme Glucose Values:
For extreme glucose values (below 80 mg/dL and greater than 250 mg/dL), 100% of the data points were within 15% of the reference analyzer result, meeting the 2016 FDA Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
2. Sample Size Used for the Test Set and Data Provenance
- Finger-stick Data Accuracy:
- Sample Size: 300 lay-user participants.
- Data Provenance: Not explicitly stated regarding country of origin, but the studies were performed by ARKRAY, Inc., based in Japan, and presented to the FDA in the USA. The study design is prospective, involving user performance.
- Alternate Site (Palm) Data Accuracy:
- Sample Size: 240 lay-user participants.
- Data Provenance: Not explicitly stated regarding country of origin, but the studies were performed by ARKRAY, Inc., and presented to the FDA in the USA. The study design is prospective, involving user performance.
- Precision (Within-Run & Intermediate):
- Sample Size: 1,500 test strips (500 per test strip lot, 300 per glucose level) for both within-run and intermediate precision. Venous whole blood samples were spiked with glucose for within-run, and glucose control solutions were used for intermediate precision.
- Data Provenance: Not specified, likely internal laboratory testing.
- Linearity:
- Sample Size: 330 test strips (across 3 lots). Venous whole blood samples spiked with glucose.
- Data Provenance: Not specified, likely internal laboratory testing.
- Accuracy at Extreme Glucose Values:
- Sample Size: 100 prepared capillary whole blood samples (50 below 80 mg/dL and 50 above 250 mg/dL).
- Data Provenance: Not specified, likely internal laboratory testing.
- Interference:
- Sample Size: Not explicitly stated as a single number of samples, but involved 27 endogenous and exogenous substances tested with venous blood samples at three glucose levels (approx. 60, 120, and 250 mg/dL). Each sample was divided into test and control pools.
- Data Provenance: Not specified, likely internal laboratory testing.
- Hematocrit:
- Sample Size: 12 blood samples with varying hematocrit levels (20%-70%), each containing five glucose levels. A single glucose determination was made using 3 different lots of test strips with 10 different meters, resulting in 30 replicates per sample aliquot.
- Data Provenance: Not specified, likely internal laboratory testing.
- Environmental Conditions:
- Sample Size: Not explicitly stated as a single number of samples, but involved 10 meters and 3 test strip lots with venous whole blood samples at 3 glucose levels tested under various temperature and humidity conditions.
- Data Provenance: Not specified, likely internal laboratory testing.
- Altitude Effects:
- Sample Size: 360 tests (across 10 meters per test strip lot, 3 test strip lots, 6 blood glucose levels, 2 sample replicates per blood glucose level).
- Data Provenance: Tested under real-life altitude conditions at sea level and at 10,335 feet (3,150 meters) above sea level. Not specified where these locations are.
- Error Codes for Samples Outside Measuring Range:
- Sample Size: Not explicitly stated as a single number of samples, but involved venous blood samples with two glucose levels (≤ 10 mg/dL and 650-700 mg/dL) tested using 3 different lots of test strips with 10 different meters.
- Data Provenance: Not specified, likely internal laboratory testing.
- Short Sample Detection:
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified, likely internal laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The ground truth for glucose measurements was established using a "YSI comparator" or "YSI reference analyzer" (YSI 2300 Biochemistry Analyzer). This is a laboratory-grade, highly accurate instrument for glucose measurement, considered the gold standard for glucose reference values in such studies. No human experts (e.g., radiologists) were involved in establishing the ground truth for glucose levels; it was an instrumental measurement.
4. Adjudication Method for the Test Set
Not applicable for this type of device. The ground truth is established by a reference instrument (YSI 2300), not by human interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic aids where human readers interpret medical images with and without AI assistance (e.g., radiology AI). The GLUCOCARD® W Blood Glucose Monitoring System is a quantitative measurement device, not an image interpretation or AI-assisted diagnostic tool in that context. The "lay-user Participants" are performing the test themselves; their performance is compared against the reference method (YSI 2300), not against other human readers or AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
While the device's measurement principle (biosensor technology) is an "algorithm" in a broad sense, the performance studies described are inherently "human-in-the-loop" studies as they involve user operation (lay-users performing finger-stick and palm tests). The precision, linearity, interference, and extreme glucose values studies evaluate the meter and test strip system's performance, which can be seen as representing the "standalone" analytical performance of the device components when operated under controlled conditions, but always with a human providing the sample. The YSI 2300 reference analyzer itself serves as the "standalone" benchmark against which the device's output is compared.
7. The Type of Ground Truth Used
The ground truth used for all performance tests (accuracy, linearity, extreme values, interference, hematocrit, altitude, error codes) was established using a YSI 2300 Biochemistry Analyzer. This is an outcomes-based, highly accurate instrumental reference method considered a gold standard for glucose measurements.
8. The Sample Size for the Training Set
The document describes performance testing for device validation and substantial equivalence, not the development or "training" of an AI algorithm or a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of GLUCOCARD® W Blood Glucose Test Strips involves calibration and quality control, but the document does not specify a "training set" in the sense of data used to train a statistical model or algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML context, this question is not applicable. For the device itself, the "ground truth" for calibration and internal performance parameters would be established through a rigorous manufacturing and quality control process, likely referencing traceable standards and highly accurate laboratory methods such as the YSI 2300. The document mentions "Automatic coded calibration" for the meter, implying an internal calibration curve is established during manufacturing.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 Nameand Address | ARKRAY Factory, Inc.1480 Koji, Konan-choKoka-shi, Shiga 520-3306 JapanEstablishment Registration # 3003422726 |
|---|---|
| Contact Person | Wendy J. Kivens, Ph.D., RAC (US)Regulatory Affairs Project Manager |
| Phone | 952-646-3142 |
| Fax | 952-646-3230 |
| kivensw@arkrayusa.com | |
| 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 |
| DeviceClassification | 21 CFR § 862.1345 |
| 510(k) Number | K170064 |
3. Predicate Device Information
| Predicate Device Name | Predicate Device510(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/CHARACTERISTIC | PROPOSED | PREDICATE |
|---|---|---|
| Blood Glucose Monitoring System | ||
| 510(k) Number | K170064 | K091102 |
| Monitoring System | GLUCOCARD® W Blood GlucoseMonitoring System | GLUCOCARD® VitalTM BloodGlucose Monitoring System |
| Intended Use andIndications for Use | The GLUCOCARD W BloodGlucose Monitoring System iscomprised of GLUCOCARD WBlood Glucose Meter andGLUCOCARD W Blood GlucoseTest Strip.The GLUCOCARD W BloodGlucose Monitoring System isintended for use in the quantitativemeasurement of glucose in freshcapillary whole blood samplesdrawn from the fingertip or palm.Testing is done outside the body ( invitro diagnostic use). It is intendedfor use at home by persons withdiabetes, as an aid in monitoringthe effectiveness of a diabetescontrol program.The GLUCOCARD W BloodGlucose Monitoring System isintended to be used by a singleperson and should not be shared.This system is not for use indiagnosis or screening of diabetesmellitus, nor for neonatal use.Alternative site testing should bedone only during steady-state times(when glucose is not changingrapidly). | The GLUCOCARD® VitalTMBlood Glucose MonitoringSystem is intended for thequantitative measurement ofglucose in fresh capillary wholeblood samples drawn from thefingertips and palms. Testing isdone outside the body ( In Vitrodiagnostic use). It is indicated foruse at home (over the counter[OTC]) by persons with diabetes,or in clinical settings byhealthcare professionals, as an aidto monitor the effectiveness ofdiabetes control.GLUCOCARD® VitalTM teststrips are intended for thequantitative measurement ofglucose in fresh capillary wholeblood samples drawn from thefingertips and palms when usedwith the GLUCOCARD® VitalTMBlood Glucose Meter. Testing isdone outside the body ( In Vitrodiagnostic use). They areindicated for use in home (overthe counter [OTC]) by personswith diabetes, or in clinicalsettings by healthcareprofessionals, as an aid to monitorthe effectiveness of diabetescontrol. |
| Measurement Method | Amperometric | Amperometric |
| Result Range | 20 to 600 mg/dL | 20 to 600 mg/dL |
| COMPONENT/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 TemperatureRange | 46°F to 104°F8°C to 40°C | 50°F to 104°F10°C to 40°C |
| Temperature Compensation | Automatic compensation usingbuilt-in thermosensor | Automatic compensation usingbuilt-in thermosensor |
| Operating Humidity Range | 10% to 90% Relative Humidity(No condensation) | 20% to 80% Relative Humidity(No condensation) |
| Maximum Altitude | 10,335 ft. (3,150 m) | 10,000 ft. (3,048 m) |
| Hematocrit Range | 20-70% | 33-52% |
| Hematocrit CorrectionFunction | Yes | No |
| Communication Function | Yes - micro USB Port | Yes – 2.5 mm jack PC InterfacePort |
| 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 Useroperation (five minutes whenwaiting for blood application) | Two minutes after last user action |
| Sample Auto DetectionFunction | Automatically detects if a sample iswhole blood or control solution | Cannot detect differences betweenwhole blood and control solution |
| Average Calculations | 7, 14, 30, 60, 90 days | 14, 30 days |
| Flag for Low Blood Sugar | Yes | No |
| COMPONENT/CHARACTERISTIC | PROPOSED | PREDICATE |
| Validated Cleaning andDisinfection 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(CR2032) |
| Chemistry | Glucose Oxidase (Aspergillus sp.)and Hexaammineruthenium (III)chloride | Glucose Oxidase (Aspergillusniger sourced) andHexaammineruthenium (III)chloride |
| Test Strip Size | 29.45 x 5.5 x 0.80 mm | 29.45 x 5.5 x 0.80 mm |
| Test Strip Color | White substrate/green dielectric | White substrate/green dielectric |
| Test Strip CalibrationCodes | Three | Three |
| Storage Temperature | 1°C to 30°C | 4°C to 30°C |
| Shelf-Life | 24 months | 24 months |
| Open Bottle Shelf-Life | 6 months after bottle opening | 3 months after bottle opening |
| Container | Molecular sieve desiccant linedplastic vial/bottle/pot | Molecular sieve desiccant linedplastic vial/bottle/pot |
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1 Although whole blood samples are used for measurement, displayed results are equivalent to plasma glucose levels.
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510(k) Summary GLUCOCARD® W Blood Glucose Monitoring System
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7. Summary of Performance Testing
Performance testing on the proposed GLUCOCARD® W Blood Glucose Monitoring System demonstrated that the device meets the performance requirements for its intended use.
INFECTION CONTROL STUDIES
The GLUCOCARD® W Blood Glucose Monitoring System is intended for single patient use only. Cleaning and Disinfection efficacy was performed on the constituent surface meter materials demonstrating complete inactivation of hepatitis B virus with the chosen disinfecting agent, Clorox Healthcare™ Bleach Germicidal Wipes (EPA #67619-12).
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ROBUSTNESS/DURABILITY
Robustness studies were performed by ARKRAY to demonstrate that there was no change in the performance or the external materials of the meter after 160 cleaning and disinfection cycles (representing weekly cleaning and disinfection for three years, the expected lifetime of the GLUCOCARD® W Blood Glucose Meter) with Clorox Healthcare™ Bleach Germicidal Wipes.
PRECISION
Within-run precision was performed using venous whole blood samples spiked with glucose to five levels. For within-run precision evaluation, samples were tested ten times with each of three lots of single test strips with ten meters for a total of 1,500 GLUCOCARD® W Blood Glucose Test Strips tested (n=500 per each test strip lot and 300 per each glucose level). Results are summarized in the table below.
| GlucoseLevel(mg/dL) | Test StripLot | Meanmg/dL | SDmg/dL | 95% CImg/dL | % CV |
|---|---|---|---|---|---|
| 30 - 50 | 1 | 42.9 | 1.8 | 1.6 to 2.1 | 4.2% |
| 30 - 50 | 2 | 44.2 | 1.9 | 1.7 to 2.2 | 4.2% |
| 30 - 50 | 3 | 40.5 | 1.4 | 1.3 to 1.7 | 3.6% |
| 51 - 110 | 1 | 72.0 | 1.7 | 1.5 to 2.0 | 2.4% |
| 51 - 110 | 2 | 74.1 | 2.0 | 1.8 to 2.4 | 2.7% |
| 51 - 110 | 3 | 72.3 | 2.3 | 2.0 to 2.7 | 3.2% |
| 111 - 150 | 1 | 144.0 | 3.7 | 3.3 to 4.3 | 2.6% |
| 111 - 150 | 2 | 149.3 | 4.9 | 4.4 to 5.9 | 3.3% |
| 111 - 150 | 3 | 149.5 | 5.1 | 4.5 to 6.2 | 3.4% |
| 151 - 250 | 1 | 227.0 | 4.8 | 4.2 to 5.6 | 2.1% |
| 151 - 250 | 2 | 234.0 | 6.5 | 5.8 to 7.8 | 2.8% |
| 151 - 250 | 3 | 235.5 | 7.7 | 6.8 to 9.6 | 3.3% |
| 251 - 400 | 1 | 369.0 | 8.8 | 7.7 to 10.2 | 2.4% |
| 251 - 400 | 2 | 379.6 | 15.8 | 14.0 to 18.3 | 4.2% |
| 251 - 400 | 3 | 385.4 | 11.6 | 10.3 to 13.8 | 3.0% |
Within-Run Precision Results
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The intermediate precision evaluation was performed with five levels of glucose control solutions. Users conducted testing over ten days using ten GLUCOCARD® W Blood Ten replicates of each control solution level were tested per Glucose Meters. GLUCOCARD® W Blood Glucose Test Strips lot. A total of three lots of GLUCARD® W Blood Glucose Test Strips were tested.
For intermediate precision evaluation, there were a total of 1,500 GLUCOCARD® W Blood Glucose Test Strips tested (n=500 per each test strip lot and 300 per each glucose level). Results are summarized in the table below.
| GlucoseLevel(mg/dL) | Test StripLot | Mean(mg/dL) | SD(mg/dL) | 95% CImg/dL | % CV |
|---|---|---|---|---|---|
| l | 41.3 | 0.8 | 0.7 to 1.0 | 1.9% | |
| 2 | 44.1 | 0.9 | 0.8 to 1.2 | 2.1% | |
| 30 - 50 | 3 | 43.6 | 0.9 | 0.8 to 1.1 | 2.0% |
| All Lots | 43.0 | ો રે | 1.4 to 1.7 | 3.5% | |
| l | 81.7 | 1.7 | 1.5 to 2.1 | 2.1% | |
| 51 - 110 | 2 | 87.6 | 1.6 | 1.4 to 2.1 | 1.8% |
| 3 | 87.4 | ો રે | 1.4 to 1.9 | 1.8% | |
| All Lots | 85.6 | 3.2 | 3.0 to 3.5 | 3.7% | |
| l | 140.4 | 2.9 | 2.6 to 3.5 | 2.1% | |
| 111 - 150 | 2 | 1 રે૦ રૂ | 2.6 | 2.3 to 3.4 | 1.7% |
| 3 | 150.4 | 2.7 | 2.4 to 3.5 | 1.8% | |
| All Lots | 147.1 | ર ર | 5.1 to 6.0 | 3.7% | |
| l | 196.0 | 4.2 | 3.7 to 5.3 | 2.1% | |
| 151 - 250 | 2 | 211.0 | 4.5 | 3.8 to 6.7 | 2.1% |
| 3 | 211.4 | 4.1 | 3.6 to 5.8 | 2.0% | |
| All Lots | 206.1 | 8.3 | 7.7 to 9.3 | 4.0% | |
| 251 - 400 | 1 | 363.7 | 10.3 | 8.8 to 14.6 | 2.8% |
| 2 | 381.7 | 8.4 | 6.9 to 13.0 | 2.2% | |
| 3 | 389.6 | 9.4 | 8.1 to 13.2 | 2.4% | |
| All Lots | 378.3 | 14.3 | 13.2 to 16.9 | 3.8% |
LINEARITY
The claimed measuring range for this device is 20-600 mg/dL.
Linearity was evaluated using venous whole blood samples spiked with glucose to eleven levels. The glucose concentration of each test sample was determined with ten GLUCOCARD® W Blood Glucose Meters. The test protocol was executed with three lots of the GLUCOCARD® W Blood Glucose Test Strips. For linearity evaluation, there were a total of 330 GLUCOCARD® W Blood Glucose Test Strips tested.
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The values from the GLUCOCARD® W Blood Glucose Monitoring System were compared with those obtained from the YSI comparator. The results from the regression analyses are summarized below.
Lot 1 y = 1.021x - 2.494; R2 = 0.999 Lot 2 y = 0.990x - 1.794; R2 = 0.999 Lot 3
The results of the linearity study support the GLUCOCARD® W Blood Glucose Monitoring System claimed glucose measurement range of 20-600 mg/dL. The meter displays "Lo" with glucose values below 20 mg/dL, and "Hi" with glucose values over 600 mg/dL. The "Lo" and "Hi" functions were validated and demonstrated to function as intended.
METHOD COMPARISON/USER EVALUATION
To assess the performance of the GLUCOCARD® W Blood Glucose Monitoring System in the using a finger-stick as the sampling site in the hands of lay-users, ARKRAY performed studies with 300 lay-user Participants. Participants were provided with labeling for the GLUCOCARD® W Blood Glucose Monitoring System. No other training or prompting was provided to the Participants. When ready, the Participants performed their own testing without assistance. Results were analyzed by comparing blood glucose results from fingerstick samples using the GLUCOCARD® W Blood Glucose Monitoring System obtained by the Participants against the reference method value (YSI 2300).
Finger-stick data on the GLUCOCARD® W Blood Glucose Monitoring System from Participants with Diabetes testing on their palm were evaluated against 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and found to be acceptable. The results are summarized the table below.
| Difference range between the true blood glucoselevel and the GLUCOCARD® W Blood GlucoseMeter result. | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|---|
| The percent (and number) of meter results thatmatch true blood glucose level within x% | 63.7%(191/300) | 92.7%(278/300) | 99.0%(297/300) | 99.7%(299/300) |
Finger-Stick Data Accuracy
To assess the performance of the GLUCOCARD® W Blood Glucose Monitoring System in the using of an Alternate Site (palm) as the sampling site in the hands of lay-users, ARKRA Y performed studies with 240 lay-user Participants. Participants were provided with labeling for the GLUCOCARD® W Blood Glucose Monitoring System. No other training or prompting was provided to the Participants. When ready, the Participants performed their own testing without assistance. Results were analyzed by comparing blood glucose results from Alternate Site Testing (AST) samples using the GLUCOCARD® W Blood Glucose Monitoring System obtained by the Participants against the reference method value (YSI 2300).
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Alternate Site (palm) data on the GLUCOCARD® W Blood Glucose Monitoring System from Participants with Diabetes testing on their palm were evaluated against 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and found to be acceptable. The results are summarized the table below.
| Alternate Site (Palm) Data Accuracy | ||
|---|---|---|
| Difference range between the true blood glucoselevel and the GLUCOCARD® W Blood GlucoseMeter result. | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|---|
| The percent (and number) of meter results thatmatch true blood glucose level within x% | 55.8%(134/240) | 88.8%(213/240) | 97.1%(233/240) | 99.2%(238/240) |
USER PERFORMANCE
A consumer study was conducted during the course of the clinical trials to evaluate the ease of use/understanding of the GLUCOCARD® W Blood Glucose Monitoring System. The study Participants stated that the GLUCOCARD® W Blood Glucose Monitoring System is 'easy to use', has 'instructions for use and messages displayed on the meter' that have 'clarity and usefulness' and that the Participant feels confident that they 'understood how to use the device correctly'.
All Participants in the consumer studies rated the GLUCOCARD® W Blood Glucose Monitoring System User Manual and the overall use of the GLUCOCARD® W Blood Glucose Monitoring System use as at least acceptable. The readability of the labeling using a Flesch-Kincaid analysis was demonstrated to be at or less than an 8th grade level.
Accuracy at Extreme Glucose Values
ARKRAY conducted a more robust evaluation between the GLUCOCARD® W Blood Glucose Monitoring System and the YSI 2300 reference analyzer in the extreme upper and lower claimed blood glucose measuring range. Fifty prepared capillary whole blood samples containing glucose concentrations below 80 mg/dL and fifty prepared capillary whole blood samples containing greater than 250 mg/dL glucose concentrations were used in this study.
When evaluated against the comparator YSI results, the values displayed on the GLUCOCARD® W Blood Glucose Meter for samples at the extreme upper and lower claimed blood glucose range generated data with 100% of the data points within 15% of reference analyzer result. These results shown in the table below meets the FDA 2016 Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use requirements.
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| Difference range between the true blood glucoselevel and the GLUCOCARD® W Blood GlucoseMeter result. | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|---|
| The percent (and number) of meter results that | 52% | 81% | 100% | 100% |
| match true blood glucose level within x% | (52/100) | (81/100) | (100/100) | (100/100) |
Extreme Glucose Values Data Accuracy
INTERFERENCE
An evaluation of potential interfering substances on the GLUCOCARD® W Blood Glucose Monitoring System was conducted. Interference was assessed for twenty-seven endogenous and exogenous substances with venous blood samples with three levels of glucose (approximately 60 mg/dL, 120 mg/dL, and 250 mg/dL). The glucose levels were verified by the YSI reference analyzer, using at least four replicates. Each sample was divided into a test pool containing the potential interfering substance and an "untreated" control pool. The relative bias (mg/dL) and percent bias was calculated using the results of the "untreated" control sample relative to the test sample for each concentration of potential interferent.
ARKRAY defined no significant interference when the average percent bias and 95% confidence interval of the test samples relative to the "untreated" control blood sample is within ± 10% at each glucose level. The results are presented in the table below.
| Potential Interferents Test Results | |
|---|---|
| Substance | Highest Concentration Testedwith no Observed Interference |
| Acetaminophen | 20 mg/dL |
| Ascorbic Acid | 4 mg/dL |
| Bilirubin Unconjugated | 40 mg/dL |
| Bilirubin Conjugated | 50 mg/dL |
| Cholesterol | 500 mg/dL |
| Creatinine | 10 mg/dL |
| L-DOPA | 5 mg/dL |
| L-Dopamine | 20 mg/dL |
| EDTA | 180 mg/dL |
| Galactose | 15 mg/dL |
| Gentisic Acid | 700 mg/dL |
| Glutathione | 92 mg/dL |
| Heparin | 500 IU/mL |
| Hemoglobin | 20 g/dL |
Potontial Intorforonts Tost Rosults
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| Substance | Highest Concentration Testedwith no Observed Interference |
|---|---|
| Ibuprofen | 50 mg/dL |
| Icodextrin | 1094.4 mg/dL |
| Maltose | 5,000 mg/dL |
| Mannitol | 100 mg/dL |
| Methyl-L-Dopa | 1000 mg/dL |
| Salicylic acid | 60 mg/dL |
| Sodium | 1015 mg/dL |
| Tolazamide | 40 mg/dL |
| Tolbutamide | 100 mg/dL |
| Triglycerides | 3,000 mg/dL |
| Uric Acid | 24 mg/dL |
| Xylitol | 0.2 mg/dL |
| Xylose | 200 mg/dL |
Based on these results. ARKRAY includes the following limitation in the labeling for the GLUCOCARD® W Blood Glucose Monitoring System:
-
- If you are taking high doses of Vitamin C (ascorbic acid; blood levels of 4 mg/dL or higher) you may get inaccurate results with this system.
HEMATOCRIT
ARKRAY evaluated the effect of hematocrit to assess whether the GLUCOCARD® W Blood Glucose Monitoring System can safely be used across the claimed hematocrit range in the intended use population. Twelve blood samples with varying hematocrit levels were created and the resulting hematocrit range of the twelve-sample panel was from 20% - 70% hematocrit. Hematocrit interference was evaluated on the twelve hematocrit samples, each containing five levels of glucose (approximately 45 mg/dL, 67 mg/dL, 134 mg/dL, 200 mg/dL, and 336 mg/dL). The glucose level for each sample was verified by the YSI reference analyzer with at least four replicates.
A single glucose determination for each sample aliquot was made using three different lots of test strips tested with ten different meters, giving a total of 30 replicates per sample aliquot. All results from the GLUCOCARD® W Blood Glucose Monitoring System supported a claim for a 20% - 70% hematocrit range.
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TEST STRIP STABILITY
Stability for the GLUCOCARD® W Blood Glucose Test Strips was evaluated through accelerated and real-time closed bottle and open bottle studies. Closed bottle stability results were reviewed and found to be acceptable to support the claims for an expiry period of 24 months for the GLUCOCARD® W Blood Glucose Test Strips with an expanded Relative Humidity at 1-30°C, 10-90% Relative Humidity. Open bottle stability results were reviewed and found to be acceptable to support an open bottle shelf life of six months for the GLUCOCARD® W Blood Glucose Test Strips.
ENVIRONMENTAL CONDITIONS
Temperature and humidity studies were performed to closely represent actual use conditions experienced by Users of the GLUCOCARD® W Blood Glucose Monitoring System. Operating temperature and humidity conditions were evaluated using ten meters and three test strip lots with venous whole blood samples at three glucose levels (approximately 67 mg/dL, 134 mg/dL, 336 mg/dL). The following temperature and Relative Humidity conditions were tested: 5-8°C / < 10% Relative Humidity, 5-8°C /> 90% Relative Humidity, 40-45°C / ≤ 10% Relative Humidity, 40-45°C / ≥ 90% Relative Humidity.
The test results support that the GLUCOCARD® W Blood Glucose Monitoring System performs in the actual use conditions experienced by Users and the claimed operating temperature from 8℃ to 40℃ and 10% to 90% Relative Humidity.
ALTITUDE EFFECTS
ARKRAY evaluated the effect of altitude on the performance of the proposed device to assess whether the GLUCOCARD® W Blood Glucose Monitoring System can safely be used up to the altitudes claimed in the labeling. Venous blood samples at six (6) glucose levels (approximately 30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL, 450-550 mg/dL) were tested under real-life altitude conditions at sea level and at 10.335 feet (3.150 meters) above sea level. The evaluation included ten meters per test strip lot, three test strip lots, six blood glucose levels, two sample replicates per blood glucose level, for a total of 360 tests. The blood glucose levels were verified by the YSI reference analyzer.
These results support the claims in the labeling that altitudes up to 10,335 feet have no significant effect on the blood glucose measurements from the GLUCOCARD® W Blood Glucose Monitoring System.
ERROR CODES FOR SAMPLES OUTSIDE THE MEASURING RANGE
Analysis was performed to demonstrate that the GLUCOCARD® W Blood Glucose Monitoring System provides the appropriate error codes when measured glucose concentration are outside of the claimed measuring range of 20-600 mg/dL. Venous blood samples with two levels of glucose (≤ 10 mg/dL and 650-700 mg/dL) were created. The glucose levels were verified by the YSI reference analyzer. Three different lots of test strips were tested using ten different meters.
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When tested, the blood glucose ≤ 10 mg/dL samples caused a "Lo" Error Code and the blood glucose 650 mg/dL samples caused a "Hi" Error Code to be displayed on the meters. Testing demonstrated that the GLUCOCARD® W Blood Glucose Monitoring System will supply the User with the appropriate error codes when measuring blood glucose concentrations that are outside of the claimed measuring range of 20-600 mg/dL. The results of this study further support that the GLUCOCARD® W Blood Glucose Monitoring System claimed measuring range of 20-600 mg/dL. The meter will display the "Lo" Error Code when the result is less than 20 mg/dL and the "Hi" Error Code when the result is greater than 600 mg/dL.
SHORT SAMPLE DETECTION
To avoid the risk of inaccurate results, GLUCOCARD® W Blood Glucose Monitoring System can detect that a short blood sample has been applied to the test strip and will not provide a result to the User. Short sample detection was assessed. Short sample testing demonstrated that the GLUCOCARD® W Blood Glucose Monitoring System requires a minimum sample volume of 0.5 µL to provide accurate glucose measurements to the User. Volumes less than 0.5 uL do not provide a glucose result to the User.
OTHER SUPPORTIVE PERFORMANCE CHARACTERISTICS STUDIES
The following tests were performed to demonstrate support for GLUCOCARD® W Blood Glucose Monitoring System claims: sample perturbation testing, intermittent sampling testing, and testing with used test strips.
8. Substantial Equivalence Conclusion
The GLUCOCARD® W Blood Glucose Monitoring System is substantially equivalent to the predicate GLUCOCARD® Vital™ Blood Glucose Monitoring System based on comparisons of the device classifications, intended use, and technological characteristics. Non-clinical and clinical performance testing successfully confirmed the suitability of the GLUCOCARD® W Blood Glucose Monitoring System for the intended uses and demonstrated the device is as safe, as effective, and perform as well as the predicate device as required per 21 CFR $ 807.92(b)(3).
§ 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.