(788 days)
No
The device description and performance studies focus on biosensor technology and electrochemical measurement, with no mention of AI or ML.
No
Explanation: This device is for in vitro diagnostic use, specifically for measuring glucose levels. It is not intended for the treatment or prevention of disease, which are characteristics of a therapeutic device.
Yes
The intended use explicitly states that the system is for the "quantitative measurement of glucose" and "is indicated for use in determining dysglycemia," which are diagnostic purposes for monitoring a medical condition.
No
The device description explicitly states that the system consists of a battery-powered meter, disposable test strips, and control solutions, which are all hardware components. The software is part of the meter but is not the sole component of the medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The Assure Titanium Blood Glucose Monitoring System is intended for in vitro diagnostic, point of care use..."
- Device Description: The description details how the device measures glucose in a blood sample using a chemical reaction on a test strip, which is a characteristic of in vitro diagnostic devices.
- Performance Studies: The performance studies describe testing the device's ability to accurately measure glucose in blood samples, which is the core function of an IVD.
The term "in vitro diagnostic" means that the device is intended for use in examining specimens derived from the human body (in this case, blood) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Assure Titanium Blood Glucose Monitoring System fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use. This system should only be use, auto-disabling lancing devices for drawing finger stick capillary blood.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use in acute care or hospital settings.
The system is not intended for neonatal use.
The system is for prescription use only.
Product codes
PZI
Device Description
The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposable test strips Assure Titanium Blood Glucose Test Strips, and control solutions. The Assure Titanium Blood Glucose Test Strips utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current (amperometry). The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the patient's glucose level.
Test principle:
The sample (whole blood) is drawn by capillary action at the tip of the test strip. As depicted in the chemical reactions listed below in Figure 1, glucose in the sample reacts with glucose oxidase (GOD) and Hexaammineruthenium (III) chloride in the test strip. This produces Hexaammineruthenium (II) chloride. Hexaammineruthenium (II) chloride is produced in proportion to the glucose concentration of the blood sample. Oxidation of the Hexaammineruthenium (II) chloride produces an electric current. The meter converts the current to the glucose concentration and displays it as the test result.
B-D-glucose + Hexaammineruthenium (II) chloride -> D-Glucono-δLactone + Hexaammineruthenium (II) chloride Hexaammineruthenium (II) chloride Electrical Charge Hexaammineruthenium (III) chloride + e-
A similar test principle is used in StatStrip Glucose Hospital Meter System previously cleared under K132121.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood samples drawn from the fingertips
Indicated Patient Age Range
Not intended for neonatal use.
Intended User / Care Setting
in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PRECISION
Within-run and intermediate precision were evaluated.
Within-run precision: evaluated using venous whole blood spiked with high concentration glucose solution or allowed to glycolyze to 5 glucose concentrations. These whole blood samples were tested on at least 10 vials of 3 test strip lots using at least 10 Assure Titanium Blood Glucose Meters. Test strips were taken from the same bottle for each meter. This resulted in 500 results on each lot, for a total of 1500 tests.
Results showed within-run precision met the overall acceptance criteria for %CV ≤ 4.2%.
Intermediate precision: evaluated using control solution adjusted to the same 5 glucose concentrations. Multiple operators tested the control solution over 10 days using at least 10 bottles of 3 test strip lots and 10 Assure Titanium meters. Test strips were taken from the same bottle for each meter. This resulted in 50 tests per lot per day for a total of 1500 tests.
Results showed intermediate precision met the overall acceptance criteria.
LINEARITY
Evaluated using glucose concentrations across the claimed glucose measuring range.
Briefly, linearity was evaluated using venous whole blood spiked with high concentration glucose solution or allowed to glycolyze to eleven evenly spaced glucose concentrations. The target glucose concentrations were verified by the YSI 2300 reference analyzer. These whole blood samples were tested on 3 test strip lots using 5 Assure Titanium Blood Glucose Meters. This resulted in 5 replicates per level per lot tested, for a total of 165 results.
Data analysis showed that linearity testing met the acceptance criteria and demonstrated linearity across the claimed measuring range of 10-600 mg/dL.
HEMOCRIT
Evaluated the effect of hematocrit on performance using venous whole blood adjusted to five glucose levels and thirteen hematocrit levels spaced 5% apart spanning the claimed hematocrit range.
Results met the target acceptance criteria. Absolute bias for glucose levels 600 mg/dL.
Acceptance criteria: All meters display "Lo" at 600 mg/dL. All results met acceptance criteria.
ERROR CODES AND FLAGGING
Evaluations performed to demonstrate error codes and flags according to design specification. Conditions triggering and not triggering error codes/flags were tested and verified.
SHORT SAMPLE DETECTION
Evaluated ability to detect short blood samples to avoid inaccurate results. Three lots of test strips tested with venous blood samples at three glucose levels (50-65, 100-120, 200-250 mg/dL) verified by YSI 2300. Approximately 0.1, 0.3, 0.5, 1, 5, or 10 uL of sample applied.
Results demonstrated either an error or an accurate result for short samples.
SAMPLE PERTURBATION
Evaluated when an appropriate blood volume is applied but an event like wicking, flicking, or meter flipping occurs. Three lots of test strips tested with venous blood samples at three glucose levels (50-65, 100-120, 200-250 mg/dL) verified by YSI 2300. Samples perturbed after application.
Results demonstrated either an error or an accurate result when the sample is perturbed.
TESTING WITH USED TEST STRIP
Evaluated automatic detection of used test strips. Three lots of test strips dosed with capillary finger-stick blood or control solution. Used strips re-inserted to produce an error.
Acceptance criteria: All used test strips produce "E1" error upon re-insertion. All test results met criteria.
SUMMARY OF CLINICAL STUDY (METHOD COMPARISON)
Multi-center study conducted at one (1) nursing/skilled nursing facility and two (2) endocrinology clinics.
Capillary blood samples from 396 patients measured and compared to YSI Model 2300 Glucose Analyzer.
Nursing/Skilled Nursing Facility (Site #1): 130 patients, 390 medical conditions, 239 medications. Range Tested: 29.0 - 405.5 mg/dL.
Endocrinology Clinic (Sites #2 and #3): 165 patients (Site #2) with 18 medical conditions and 245 medications; 101 patients (Site #3) with 61 medical conditions and 196 medications. Total 266 patients for endocrinology clinic data, K950567 refers to 266 subjects for combined clinic data. Range Tested: 43.7 - 492.5 mg/dL.
Slope: 0.98 for both facility types. Correlation 'r': 0.99 for both facility types.
Accuracy for 300 mg/dL) collected and tested.
Results for Glucose Concentrations 300 mg/dL: 100% within ±12%.
Demonstrated highly accurate glucose results in extreme ranges.
USABILITY
POC operator evaluation study during clinical trial. Two usability questionnaires concerning ease of use of the blood glucose meter system and understanding of the User Manual and Quick Reference Guide (QRG).
100% of responses were positive (Very Easy, Easy, or OK).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PRECISION:
Within-run precision: %CV ≤ 4.2% (acceptance criteria).
Intermediate precision: %CV met overall acceptance criteria.
LINEARITY:
R2 values for linear regression: 0.9988, 0.9993, 0.9999.
100% of measurements fell within ±15% at 300 mg/dL:
Within ±5%: 32/50 (64%)
Within ±10%: 46/50 (92%)
Within ±12%: 50/50 (100%)
Within ±15%: 50/50 (100%)
Within ±20%: 50/50 (100%)
Exceeds ±20%: 0/50 (0%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 23, 2022
Arkray, Inc. Dhwani Thakkar Regulatory Affairs Project Manager 5182 West 76th Street Minneapolis, MN 55439
Re: K200788
Trade/Device Name: Assure® Titanium Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: PZI Dated: June 14, 2021 Received: June 15, 2021
Dear Dhwani Thakkar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200788
Device Name
Assure® Titanium Blood Glucose Monitoring System
Indications for Use (Describe)
· The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use. This system should only be use, auto-disabling lancing devices for drawing finger stick capillary blood.
• The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
- · The system is not intended for use in acute care or hospital settings.
- · The system is not intended for neonatal use.
- · The system is for prescription use only.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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1. Administrative Information
| Applicant's Name
and Address | Yoshiharu Uehata
ARKRAY, Inc.
Yousuien-nai, 59 Gansuin-cho
Kamigyo-ku, Kyoto 602-0008 Japan
Establishment Registration # 3003422726 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Dhwani Thakkar
Regulatory Affairs Project Manager
ThakkarD@arkrayusa.com |
| Secondary Contact | Daya Ranamukhaarachchi, PhD
V.P. Regulatory and Scientific Affairs
RanamukD@arkrayusa.com |
| Phone | 408-234-0804 |
| Fax | 1-855-924-2725 |
| Email | RanamukD@arkrayusa.com |
| Date Prepared | June 14, 2021 |
2. Device Information
Device
| Trade Name | Assure® Titanium Blood Glucose Monitoring System |
|---|---|
| 510(k) Number | K200788 |
| Classification Name | Prescription Use Blood Glucose Meter for Near-Patient |
| Testing | |
| Common Name | Glucose Test System |
| Product Code | PZI |
| Classification Panel | 75 – Clinical Chemistry |
| Device | |
| Classification | 21 CFR § 862.1345 |
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3. Predicate Device Information
| Predicate Device Name | Predicate Device
510(k) Number |
|-----------------------------------------|-----------------------------------|
| StatStrip Glucose Hospital Meter System | K132121 |
4. Device Description
The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposable test strips Assure Titanium Blood Glucose Test Strips, and control solutions. The Assure Titanium Blood Glucose Test Strips utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current (amperometry). The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the patient's glucose level.
Test principle:
The sample (whole blood) is drawn by capillary action at the tip of the test strip. As depicted in the chemical reactions listed below in Figure 1, glucose in the sample reacts with glucose oxidase (GOD) and Hexaammineruthenium (III) chloride in the test strip. This produces Hexaammineruthenium (II) chloride. Hexaammineruthenium (II) chloride is produced in proportion to the glucose concentration of the blood sample. Oxidation of the Hexaammineruthenium (II) chloride produces an electric current. The meter converts the current to the glucose concentration and displays it as the test result.
B-D-glucose + Hexaammineruthenium (II) chloride -> D-Glucono-δLactone + Hexaammineruthenium (II) chloride Hexaammineruthenium (II) chloride Electrical Charge Hexaammineruthenium (III) chloride + e-
Figure 1: Principle of Action for Assure Titanium Blood Glucose Monitoring System
A similar test principle is used in StatStrip Glucose Hospital Meter System previously cleared under K132121.
5. Indications for Use
The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test
5
strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing or skilled nursing facilities, for multiple patient use. This system should only be used with single-use, auto-disabling lancing devices for drawing finger stick capillary blood.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use in acute care or hospital settings.
The system is not intended for neonatal use.
The system is for prescription use only.
6. Substantial Equivalence Information
The Assure Titanium Blood Glucose Monitoring Device uses similar intended use as the predicate, StatStrip Glucose Hospital Meter System. Also, test principle and technology are similar for both devices. Table 1 below provides a comparison between the Assure Titanium Blood Glucose Monitoring System and its predicate device.
As described in the performance testing summary below, the verification and validation (bench and clinical) testing successfully demonstrated substantial equivalence for the Assure Titanium Blood Glucose Monitoring System to the predicate device as required per 21 CFR § 807.92(b)(3).
| Table 1: Similarities and Differences Table | ||||
|---|---|---|---|---|
| COMPONENT/
| CHARACTERISTIC | PROPOSED | PREDICATE |
|---|---|---|
| 510(k) Number | K200788 | K132121 |
| Device/Measuring | ||
| System | Assure® Titanium | |
| Blood Glucose | ||
| Monitoring System | StatStrip Glucose | |
| Hospital Meter | ||
| System | ||
| COMPONENT/ | ||
| CHARACTERISTIC | PROPOSED | PREDICATE |
| Intended Use and | ||
| Indications for Use | The Assure Titanium | |
| Blood Glucose | ||
| Monitoring System | ||
| consists of the Assure | ||
| Titanium Blood | ||
| Glucose meter and the | ||
| Assure Titanium | ||
| Blood Glucose test | ||
| strips. The Assure | ||
| Titanium Blood | ||
| Glucose Monitoring | ||
| System is intended for | ||
| use in the quantitative | ||
| For the quantitative | ||
| determination of | ||
| glucose in capillary | ||
| finger stick, venous | ||
| whole blood, arterial | ||
| whole blood, neonate | ||
| arterial whole blood | ||
| and neonate heel stick | ||
| specimens. Also for | ||
| the quantitative | ||
| determination of | ||
| glucose in venous | ||
| whole blood, arterial | ||
| whole blood, | ||
| neonatal heel stick, | ||
| and neonatal arterial | ||
| whole blood | ||
| throughout all | ||
| hospital and all | ||
| professional | ||
| healthcare settings. | ||
| intended for neonatal | ||
| use. | ||
| The system is for | ||
| prescription use only. | ||
| Population limitation | Not intended for | |
| neonatal use, acute | ||
| care or hospital | ||
| settings, nor for use | ||
| with patients | ||
| receiving intensive | ||
| medical | ||
| intervention/therapy. | Not intended for | |
| patients receiving | ||
| intensive medical | ||
| intervention/therapy. | ||
| This system is | ||
| intended for use with | ||
| neonatal arterial whole | ||
| blood but has not been | ||
| validated for neonatal | ||
| venous blood. | ||
| Sample Type | Fresh capillary whole | |
| blood* | Whole Blood: | |
| Capillary, Venous, | ||
| Arterial, and Neonate | ||
| arterial whole blood | ||
| Test Strip Ejector | Yes | No |
| Controls | 3 levels of Assure | |
| Control- Control | ||
| Solutions | 3 levels of Nova | |
| StatStrip Control | ||
| Solutions | ||
| Maximum | ||
| Altitude | 10,000 ft (3,048 | |
| meters) | 15,000 ft (4500 | |
| meters) | ||
| Sample Volume | 0.5 µL | 1.2 µL |
| Weight | 4.1 oz with batteries | 9.6 oz |
| Dimensions | 4.7 x 2.4 x 1.2 inch | 6.0 x 3.25 x 1.8 inch |
| Battery/Power | ||
| source | Two 1.5V alkaline | |
| AAA batteries | 3.7V Li Polymer | |
| battery | ||
| (Rechargeable/Replace | ||
| able) | ||
| Operating | ||
| Temperature range | 46-104°F (8-40°C) | 59-104 °F (15-40°C) |
| Hematocrit Range | 10-70% | 20-65% |
| Data Storage | 1,000 test results | 1,000 Patient Tests |
| 200 QC Tests | ||
| 4000 Operators | ||
| Measuring Time | 7 seconds | 6 seconds |
| Electrical | ||
| Compliance | Conforms to | |
| ANSI/AAMI IEC | ||
| 60601-1-2:2014 | Conforms to: | |
| IEC 61010-1:2001 and | ||
| IEC 61010-2-101:2002 | ||
| Measuring Range | 10-600 mg/dL | 10-600 mg/dL |
| Relative Humidity | 10-90% (no condensation) | 10-90% (no condensation) |
| Enzyme | Glucose oxidase | |
| (Aspergillus niger sourced) | Glucose Oxidase | |
| (Aspergillus sourced) | ||
| Test Principle | Electro-chemical | |
| biosensor | ||
| (Amperometric) | Electro-chemical | |
| biosensor | ||
| (Amperometric) | ||
| Calibration | Automatic coded | |
| calibration | Automatic, no | |
| calibration code | ||
| Wi-Fi network | ||
| connectivity | No | No |
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7
8
- Although whole blood samples are used for measurement, displayed results are equivalent to plasma glucose levels.
7. Summary of Performance Testing
Performance testing was conducted on the proposed Assure Titanium Blood Glucose Monitoring System in accordance with the FDA guidance Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, 2016 and 2020 using final product. Performance testing demonstrated that the device meets the performance requirements for its intended use.
PRECISION
Within-run and intermediate precision for the Assure Titanium Blood Glucose Monitoring System were evaluated to assess imprecision of the system across the glucose measuring range and under normal use conditions.
Briefly, within-run precision was evaluated using venous whole blood spiked with high concentration glucose solution or allowed to glycolyze to 5 glucose concentrations. These whole blood samples were tested on at least 10 vials of 3 test strip lots using at least 10 Assure Titanium Blood Glucose Meters. Test strips were taken from the same bottle for each meter. This resulted in 500 results on each lot, for a total of 1500 tests.
Results for the within-run precision testing are shown in Table 2, mean results for each glucose level are presented for each lot with associated standard deviation (SD), percent coefficient of variation (%CV) and the 95% confidence intervals.
9
| Lot # | Glucose Level
(mg/dL) | Mean (mg/dL) | SD | 95% CI | %CV |
|-------|--------------------------|--------------|------|-------------|------|
| 280-2 | 30-50 | 45.7 | 1.2 | 1.0 to 1.4 | 2.6% |
| | 51-110 | 96.3 | 2.0 | 1.6 to 2.4 | 2.1% |
| | 111-150 | 140.2 | 3.1 | 2.5 to 3.6 | 2.2% |
| | 151-250 | 203.7 | 6.2 | 5 to 7.5 | 3.1% |
| | 251-400 | 324.3 | 10.1 | 8.1 to 12.1 | 3.1% |
| 280-4 | 30-50 | 44.4 | 1.3 | 1.0 to 1.5 | 2.9% |
| | 51-110 | 95.7 | 2.0 | 1.6 to 2.4 | 2.1% |
| | 111-150 | 139.6 | 2.8 | 2.2 to 3.3 | 2.0% |
| | 151-250 | 204.9 | 3.8 | 3.1 to 4.6 | 1.9% |
| | 251-400 | 324.2 | 7.5 | 6.1 to 9 | 2.3% |
| 280-5 | 30-50 | 42.6 | 1.0 | 0.8 to 1.2 | 2.4% |
| | 51-110 | 92.8 | 2.3 | 1.8 to 2.7 | 2.4% |
| | 111-150 | 137.8 | 3.2 | 2.6 to 3.9 | 2.3% |
| | 151-250 | 202.7 | 4.9 | 3.9 to 5.8 | 2.4% |
| | 251-400 | 324.1 | 8.7 | 7 to 10.4 | 2.7% |
Table 2: Within-Run Precision Results for Assure Titanium Blood Glucose Monitoring System
The data in Table 2 demonstrate the within-run precision met the overall acceptance criteria for %CV ≤ 4.2% for the Assure Titanium Blood Glucose Monitoring System.
Intermediate precision was evaluated using control solution adjusted to the same 5 glucose concentrations. Multiple operators tested the control solution over 10 days using at least 10 bottles of 3 test strip lots and 10 Assure Titanium meters. Test strips were taken from the same bottle for each meter. This resulted in 50 tests per lot per day for a total of 1500 tests.
Results for intermediate precision testing for all lots are shown in Table 3. Mean results for each glucose level are presented with associated standard deviation (SD), percent coefficient of variation (%CV) and the 95% confidence intervals.
10
| | Glucose Level
(mg/dL) | Mean (mg/dL) | SD | 95% CI | %CV |
|----------------------|--------------------------|--------------|-----|------------|-----|
| All Lots
Combined | 30-50 | 42.4 | 0.8 | 0.6 to 0.9 | 1.9 |
| | 51-110 | 87.0 | 1.4 | 1.1 to 1.7 | 1.6 |
| | 111-150 | 129.3 | 1.8 | 1.4 to 2.1 | 1.4 |
| | 151-250 | 254.7 | 3.9 | 3.2 to 4.7 | 1.5 |
| | 251-400 | 360.6 | 7.5 | 6.0 to 9.0 | 2.1 |
Table 3: Intermediate Precision Results for Assure Titanium
The data in Table 3 show that Intermediate precision met the overall acceptance criteria.
LINEARITY
Linearity for the Assure Titanium Blood Glucose Monitoring System was evaluated using glucose concentrations across the claimed glucose measuring range and data was analyzed according to CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement: A Statistical Approach; An Approved Guideline.
Briefly, linearity was evaluated using venous whole blood spiked with high concentration glucose solution or allowed to glycolyze to eleven evenly spaced glucose concentrations. The target glucose concentrations were verified by the YSI 2300 reference analyzer. These whole blood samples were tested on 3 test strip lots using 5 Assure Titanium Blood Glucose Meters. This resulted in 5 replicates per level per lot tested, for a total of 165 results.
Data analysis included linear regression with regression equation and coefficient of determination (R2) presented for each lot tested and presented in Table 4.
| Lot | Linear Regression Equation | R2 |
|---|---|---|
| Type 280-1 | y = 1.0079x + 3.9485 | 0.9988 |
| Type 302-1 | y = 1.0063x + 3.3727 | 0.9993 |
| Type 302-2 | y = 0.9902x + 2.1839 | 0.9999 |
Table 4: Linear Regression Equation for All Assure Titanium Blood Glucose Monitoring System Lots
Data analysis showed that linearity testing met the acceptance criteria in that all measurements fell within the ranges shown in Table 5, demonstrating linearity of the Assure Titanium Blood Glucose Monitoring System across the claimed measuring range of 10-600 mg/dL.
Table 5: Assure Titanium Blood Glucose Monitoring System Comparison to YSI 2300 Reference
| Lot | Within ±15% at 600 mg/dL). The acceptance criteria were as follows: All meters to display "Lo" at glucose levels 600 mg/dL.
All results met the acceptance criteria demonstrating that the Assure Titanium Blood Glucose Monitoring System will supply the user with the appropriate error codes when measuring blood glucose concentrations outside of the claimed measuring range.
ERROR CODES AND FLAGGING
ARKRAY performed evaluations to demonstrate that the Assure Titanium Blood Glucose Monitoring System provides error codes and flags according to the design specification. Please see Table 7 below for details on the error codes/flags evaluated.
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| Table 7: Assure Titanium Blood Glucose Monitoring System Error Codes and Flags | |
|---|---|
| Error Code | Description |
| E-1 | Test strip was previously used. Retest with a new test strip. |
| E-2 | Meter malfunction. Contact customer service. |
| E-3 | Temperature too high or too low. Move to an area with a temperature between 50°F and 104°F (10°C and 40°C) and retest. |
| E-4 | Test strip is damaged or was not properly inserted. Retest with a new test strip. |
| E-5 | Blood sample was applied before the flashing blood drop symbol appeared. Retest with a new test strip. |
| E-6 | Not enough blood was applied to the test strip. Retest with a new test strip. |
| E-7 | Control solution test result is out of range. Repeat the control solution test. |
| E-8 | Meter malfunction. Contact customer service. |
| E-9 | Test strip error. Retest with a new test strip. |
| E-10 | Meter malfunction. Contact customer service. |
| E6 | Occurs when the temperature is outside the
temperature operating range |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| E5 | Occurs when an abnormal sample is detected,
the contact bars of the test strips are dirty, or
an incorrect sample type is used |
| E0 | Occurs when measurement of blood sample is
attempted during QC lockout |
| Control Solution Flag | Meter displays control flag when control
solution is tested |
| Temperature Flag | Occurs alongside E6 when the temperature is
outside the temperature operating range |
For each error code/flag listed in Table 7, the appropriate conditions that trigger the error code/flag were tested and the error code/flag was verified. Additionally, conditions that should not trigger the error code/flag were also tested and the absence of the error code/flag was verified.
SHORT SAMPLE DETECTION
Blood glucose measurement from short samples of reduced sample volume) can lead to inaccurate results. To avoid the risk of inaccurate results, Blood Glucose Monitoring Systems should be able to detect that a short blood sample has been applied to the test strip and should not provide a result.
Three lots of Assure Titanium test strips were tested with venous blood samples at three glucose levels (50-65. 100-120, 200-250 mg/dL) that were verified using the YS1 2300. Approximately 0.1. 0.3. 0.5. 1. 5. or 10 uL of sample was applied to the test strip. Once the countdown was completed (if initiated), an error or the test result displayed on the meter.
The results demonstrated that the Assure Titanium Blood Glucose Monitoring System will either produce an error or an accurate result when short sampled.
SAMPLE PERTURBATION
Sample perturbation occurs when an appropriate volume of blood is applied to the test strip for glucose measurement, but an event such as wicking of blood away from the test strip, flicking of the test strip or flipping of the meter occurs during the start of the measurement and potentially alters the volume of the initial sample application.
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Three lots of Assure Titanium test strips were tested with venous blood samples at three glucose levels (50-65, 100-120, 200-250 mg/dL) that were verified using the YSI 2300. The samples were applied to the test strip and then perturbed by flicking the test strip, flipping the meter on theside, and wicking the sample away using a tissue.
The results demonstrated that the Assure Titanium Blood Glucose Monitoring System either provides an error or an accurate result when the sample is perturbed.
TESTING WITH USED TEST STRIP
The Assure Titanium Blood Glucose Monitoring System is designed to automatically detect the insertion of used Assure Titanium Blood Glucose Test Strips into the Assure Titanium Blood Glucose Meter. Insertion of used Assure Titanium Blood Glucose Test Strips into the system should not provide glucose measurement results.
Three lots of Assure Titanium test strips were dosed with either capillary finger-stick blood or control solution. The used test strips were then re-inserted into Assure Titanium meters to produce an error. The target acceptance criteria are as follow: All used test strips shall produce the E1 error upon re-insertion. All test results met the acceptance criteria.
SUMMARY OF CLINICAL STUDY (METHOD COMPARISON)
The Assure Titanium Blood Glucose Meter and Assure Titanium Blood Glucose Test Strips for the Assure Titanium Blood Glucose Monitoring System were tested in a multi-center study conducted at one (1) nursing/skilled nursing facility and two (2) endocrinology clinics to demonstrate clinical performance with patients/subjects in whom routine glucose monitoring is done in these settings.
Nursing/skilled nursing facility (Site #1) is a 475-bed institution in the state of Massachusetts. The study took place across both long-term care nursing and temporary care/rehabilitation units. The study was conducted by Point-of-Care operators who took capillary blood samples from 130 patients . Patients in this study represented 390 medical conditions and 239 different medications. Site #2 is an endocrinology clinic located in the state of California. Point-of-Care operators took capillary blood samples from 165 patients in this study represented 18 medical conditions and 245 different medications. Site #3 is an endocrinology clinic located in the state of Georgia. Point-of-Care operators took capillary blood samples from 101 patients. Patients in this study comprised 61 medical conditions and 196 different medications.
In total, capillary blood samples from 396 patients were measured and the results were compared to the YSI Model 2300 Glucose Analyzer, a lab instrument (comparator method). The tables 8-12 below show differences in glucose values between the Assure Titanium Blood Glucose Meter and the YSI method.
The slope, correlation, intercept, standard error, and 95% confidence interval as shown in Table 8 represent a strong linear correlation between the Assure Titanium Blood Glucose Monitoring System and the YSI 2300 reference analyzer.
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| Results obtained by healthcare professionals | ||
|---|---|---|
| Nursing/Skilled | ||
| Nursing Facility | Endocrinology Clinic | |
| Slope | 0.98 | 0.98 |
| Correlation 'r' | 0.99 | 0.99 |
| Intercept | 3.24 | 2.83 |
| Number of Samples | 130 | 266 |
| Range Tested | 29.0 - 405.5 mg/dL | 43.7 - 492.5 mg/dL |
Table 8: Assure Titanium Blood Glucose Monitoring System Correlation
Table 9: Nursing/Skilled Nursing Facility Accuracy results for glucose concentrations 300 mg/dL.
The data for the Accuracy at Extremes Glucose Values study are presented in Table 15 below.
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| Glucose Concentrations 300 mg/dL | | | | | |
| Within ±5% | Within ±10% | Within ± 12% | Within ±
15% | Within ±20% | Exceeds ±20% |
| 32/50 (64%) | 46/50 (92%) | 50/50
(100%) | 50/50
(100%) | 50/50 (100%) | 0/50 (0%) |
Table 15: Accuracy at extreme glucose value results for Assure Titanium Blood Glucose Monitoring System vs YSI 2300 Reference Analyzer
The results from this study demonstrated the proposed Assure Titanium Blood Glucose Monitoring System provides highly accurate glucose results when testing in the extreme glucose ranges.
USABILITY
A POC operator evaluation study was conducted during the clinical trial to evaluate the ease of use/understanding of the Assure Titanium Blood Glucose Monitoring System. The POC operator study involved POC operators filling out two usability questionnaires; one concerning the ease of use of the blood glucose meter system and one the ease of understanding of the Assure Titanium User Manual and the Quick Reference Guide (QRG). All the responses (100% combined) were positive i.e., Very Easy, or OK and indicated that the Assure Titanium Blood Glucose Monitoring System is easy to use. The overall rating of understanding the Quick ReferenceGuide and User Manual for Assure Titanium Blood Glucose Monitoring System was positive with participants rating 100% in categories of Very Easy, Easy or OK (combined).
Expected Values
Expected values for non-diabetics Expected blood glucose values for non-pregnant adults without diabetes l Fasting*