(219 days)
Not Found
No
The device description and performance studies focus on biosensor technology and electrochemical detection, with no mention of AI or ML algorithms for data processing or interpretation.
No.
Explanation: This device is an in vitro diagnostic (IVD) device used to measure glucose levels, which aids in monitoring a diabetes control program. It does not directly treat or prevent a disease; rather, it provides diagnostic information.
No.
The "Intended Use / Indications for Use" section explicitly states, "This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use." This indicates that the device is intended for monitoring purposes by individuals already diagnosed with diabetes, not for diagnosing the condition itself.
No
The device is described as a "Blood Glucose Monitoring System" comprised of a "Blood Glucose Meter" and "Blood Glucose Test Strips." The description explicitly mentions a "battery-powered GLUCOCARD® W Blood Glucose Meter" and "disposable GLUCOCARD® W Blood Glucose Test Strips," which are hardware components. The performance studies also detail testing of the meter and test strips, including physical characteristics like cleaning, disinfection, and environmental conditions.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (in vitro diagnostic use)."
Furthermore, the device description and the nature of the test (measuring glucose in a blood sample outside the body) align with the definition of an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
NBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
INFECTION CONTROL STUDIES
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).
ROBUSTNESS/DURABILITY
Robustness studies were performed 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).
The intermediate precision evaluation was performed with five levels of glucose control solutions. Users conducted testing over ten days using ten GLUCOCARD® W Blood Glucose Meters. Ten replicates of each control solution level were tested per 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).
LINEARITY
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. The values from the GLUCOCARD® W Blood Glucose Monitoring System were compared with those obtained from the YSI comparator. The result of the linearity study supports the 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. These 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 found to be acceptable when evaluated against 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. Specifically, 63.7% (191/300) of results were within ±5%, 92.7% (278/300) within ±10%, 99.0% (297/300) within ±15%, and 99.7% (299/300) within ±20%.
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).
Alternate Site (palm) data on the GLUCOCARD® W Blood Glucose Monitoring System found to be acceptable when evaluated against 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. Specifically, 55.8% (134/240) of results were within ±5%, 88.8% (213/240) within ±10%, 97.1% (233/240) within ±15%, and 99.2% (238/240) within ±20%.
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. Specifically, 52% (52/100) of results were within ±5%, 81% (81/100) within ±10%, 100% (100/100) within ±15%, and 100% (100/100) within ±20%.
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.
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.
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 / 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for accuracy metrics related to finger-stick, alternate site, and extreme glucose value testing.
Precision:
Within-run precision: %CV values range from 2.1% to 4.2% across glucose levels (30-400 mg/dL) and test strip lots.
Intermediate precision: %CV values range from 1.7% to 4.0% across glucose levels (30-400 mg/dL) and test strip lots.
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.
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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.
1
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 Name
and Address | ARKRAY Factory, Inc.
1480 Koji, Konan-cho
Koka-shi, Shiga 520-3306 Japan
Establishment Registration # 3003422726 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Wendy J. Kivens, Ph.D., RAC (US)
Regulatory Affairs Project Manager |
| Phone | 952-646-3142 |
| Fax | 952-646-3230 |
| Email | 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 |
| Device | |
| Classification | 21 CFR § 862.1345 |
| 510(k) Number | K170064 |
3. Predicate Device Information
| Predicate Device Name | Predicate Device
510(k) Number |
|---------------------------------------------------|-----------------------------------|
| GLUCOCARD® Vital™ Blood Glucose Monitoring System | K091102 |
ப
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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 Glucose | |
| Monitoring System | GLUCOCARD® VitalTM Blood | |
| Glucose Monitoring System | ||
| Intended Use and | ||
| Indications for Use | The GLUCOCARD W Blood | |
| Glucose Monitoring System is | ||
| comprised of GLUCOCARD W | ||
| Blood Glucose Meter and | ||
| GLUCOCARD W Blood Glucose | ||
| Test Strip. | ||
| 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® VitalTM | |
| Blood Glucose Monitoring | ||
| System is intended for the | ||
| quantitative measurement of | ||
| glucose in fresh capillary whole | ||
| blood samples drawn from the | ||
| fingertips and palms. Testing is | ||
| done outside the body ( In Vitro | ||
| diagnostic use). It is indicated for | ||
| use at home (over the counter | ||
| [OTC]) by persons with diabetes, | ||
| or in clinical settings by | ||
| healthcare professionals, as an aid | ||
| to monitor the effectiveness of | ||
| diabetes control. | ||
| GLUCOCARD® VitalTM test | ||
| strips are intended for the | ||
| quantitative measurement of | ||
| glucose in fresh capillary whole | ||
| blood samples drawn from the | ||
| fingertips and palms when used | ||
| with the GLUCOCARD® VitalTM | ||
| Blood Glucose Meter. Testing is | ||
| done outside the body ( In Vitro | ||
| diagnostic use). They are | ||
| indicated for use in home (over | ||
| the counter [OTC]) by persons | ||
| with diabetes, or in clinical | ||
| settings by healthcare | ||
| professionals, as an aid to monitor | ||
| the effectiveness of diabetes | ||
| control. | ||
| 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 Temperature | ||
| Range | 46°F to 104°F | |
| 8°C to 40°C | 50°F to 104°F | |
| 10°C to 40°C | ||
| Temperature Compensation | Automatic compensation using | |
| built-in thermosensor | Automatic compensation using | |
| built-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 Correction | ||
| Function | Yes | No |
| Communication Function | Yes - micro USB Port | Yes – 2.5 mm jack PC Interface |
| 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 | |
| operation (five minutes when | ||
| waiting for blood application) | Two minutes after last user action | |
| Sample Auto Detection | ||
| Function | Automatically detects if a sample is | |
| whole blood or control solution | Cannot detect differences between | |
| whole 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 and | ||
| 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 |
| (CR2032) | ||
| Chemistry | Glucose Oxidase (Aspergillus sp.) | |
| and Hexaammineruthenium (III) | ||
| chloride | Glucose Oxidase (Aspergillus | |
| niger sourced) and | ||
| Hexaammineruthenium (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 Calibration | ||
| Codes | 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 lined | |
| plastic vial/bottle/pot | Molecular sieve desiccant lined | |
| plastic 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.
| Glucose
Level
(mg/dL) | Test Strip
Lot | Mean
mg/dL | SD
mg/dL | 95% CI
mg/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.
| Glucose
Level
(mg/dL) | Test Strip
Lot | Mean
(mg/dL) | SD
(mg/dL) | 95% CI
mg/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 glucose
level and the GLUCOCARD® W Blood Glucose
Meter result. | Within ±
5% | Within ±
10% | Within ±
15% | Within ±
20% |
|--------------------------------------------------------------------------------------------------------------|--------------------|--------------------|--------------------|--------------------|
| The percent (and number) of meter results that
match 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 glucose
level and the GLUCOCARD® W Blood Glucose
Meter result. | Within ±
5% | Within ±
10% | Within ±
15% | Within ±
20% |
|--------------------------------------------------------------------------------------------------------------|--------------------|--------------------|--------------------|--------------------|
| The percent (and number) of meter results that
match 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 glucose
level and the GLUCOCARD® W Blood Glucose
Meter 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 Tested |
| with 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 Tested
with 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 / 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).