(114 days)
No
The document describes a standard electrochemical blood glucose monitoring system that measures electrical current produced by a chemical reaction. There is no mention of AI or ML in the device description, intended use, performance studies, or key metrics. The data transfer features (USB and Bluetooth) are for transmitting raw glucose readings, not for processing or interpreting data using AI/ML.
No.
The device is an in vitro diagnostic device intended for quantitative measurement of glucose, not for therapeutic interventions.
Yes
The device is explicitly stated to be for "in vitro diagnostic use" and is intended for "quantitative measurement of glucose" as an "aid to monitoring the effectiveness of diabetes control programs," which are diagnostic functions.
No
The device is explicitly described as a "Blood Glucose Monitoring System" comprised of a "Blood Glucose Meter" and "Blood Glucose Test Strips," which are hardware components. While there is mention of a Bluetooth module for data transfer and potential software integration (On Call Diabetes Management Software), the core medical device functionality relies on physical hardware for glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use."
and
"The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use."
This statement directly identifies the device as an in vitro diagnostic product. The device measures glucose in a sample of blood taken from the body, which is the definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Product codes
NBW
Device Description
The On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System are designed for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm.
Both systems have almost the same meter design and use the same strip and control solution. The only difference is that On Call Sure Sync Blood Glucose meter is embedded with a Bluetooth module which results in an additional Bluetooth data transfer feature for this meter. Thus, the On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System can be considered equivalent for the performance of glucose testing.
Both systems share the same On Call Sure Blood Glucose test strip. It has a reagent system that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample to produce an electrical current signal. This current is measured using an amperometric detection method. The meter then calculates and displays the blood glucose concentration reading, calibrated to plasma reference. The On Call Sure / On Call Sure Sync Blood Glucose Meters are auto-coding.
Both systems consist of the On Call Sure / On Call Sure Sync Blood Glucose Meter, On Call Sure Blood Glucose Test Strips, and On Call Sure Glucose Control Solutions. Kits may be marketed with various combinations and quantities of the system components, or each of the components may be sold separately. All meter kits include a Carrying Case, User's Manual, Quick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets.
The On Call Sure Glucose Control Solutions are used to confirm that the meter and test strips are working properly. Glucose control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. Two control solution levels are available (Level 1 and Level 2). Level 1 is provided with the system. Level 2 is sold separately.
Both meters have a USB data transfer function that is inactive, pending validation with the On Call Diabetes Management Software (K131469). Only the On Call Sure Sync Blood Glucose Meter is equipped with Bluetooth.
The On Call Sure Sync Blood Glucose Meter is designed with a Bluetooth module which can send glucose test results to a mobile device if the glucose meter and the mobile device are paired and within range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm and palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
self-testing by people with diabetes at home
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
User Evaluation Study:
Sample Size: 366 subjects participated in the study with 3 lots of strips (n=122/lot), including 38 subjects who indicated in the Case Report Form that they were naive users of blood glucose monitoring systems.
Data Source: Capillary blood samples from fingertip, palm, and forearm.
Annotation Protocol: Study participants measured their own capillary blood samples using the On Call Sure Sync Blood Glucose Monitoring System according to the manual reading understanding. Trained technicians collected capillary blood samples in microtainer tubes (with heparin anticoagulant) to be measured on the YSI 2300 Stat Plus Glucose Analyzer in duplicate as the reference.
Accuracy at Extreme Glucose Values Study:
Sample Size: 149 capillary blood samples from the user evaluation study (88 samples for low glucose levels, 61 for high glucose levels).
Data Source: Capillary blood samples from subjects in the user evaluation study, which were either glycolyzed to obtain glucose concentrations 250 mg/dL.
Annotation Protocol: Each contrived blood sample was measured with the SMBG in duplicate for each lot. The reference method for comparison was YSI 2300 Stat Plus.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-Clinical Tests Performed for Determination of Substantial Equivalence, Laboratory Performance Testing (Precision/Reproducibility, Linearity/assay reportable range, Traceability/Stability/Expected values, Detection limit, Analytical specificity), Clinical Tests (User Evaluation Study, Accuracy at Extreme Glucose Values Study).
Sample Size:
- Repeatability Precision: Ten replicate assays on ten On Call Sure Sync Blood Glucose Meters using heparinized venous blood samples at six concentration levels.
- Intermediate Precision: Ten replicate assays from three strip lots on ten On Call Sure Sync Blood Glucose Meters, run each day for ten days, using control solutions at six concentration levels.
- Linearity/assay reportable range: 3 lots of test strips, 10 meters.
- Clinical User Evaluation Study: 366 subjects with 3 lots of strips (122 subjects per lot).
- Accuracy at Extreme Glucose Values Study: 149 capillary blood samples (88 for low glucose, 61 for high glucose).
Key Results:
Precision/Reproducibility:
- Repeatability Precision (Mean Glucose and SD/CV):
- 42.6 mg/dL: 1.24 mg/dL
- 82.2 mg/dL: 2.28 mg/dL
- 133.3 mg/dL: 2.5 %
- 205.1 mg/dL: 2.5 %
- 334.6 mg/dL: 2.6 %
- 517.6 mg/dL: 2.2 %
- Intermediate Precision (Mean Glucose and SD/CV for 3 Strip Lots): Values provided for 6 concentration levels (e.g., Strip Lot 1: 36.0 mg/dL - 0.91 mg/dL; 432.2 mg/dL - 2.3%).
Linearity/Assay Reportable Range:
- Linear regression analysis for each test strip lot compared to YSI:
- Lot 1: y = 1.0055x + 0.3755; R² = 0.9976
- Lot 2: y = 1.0023x - 0.3007; R² = 0.9976
- Lot 3: y = 0.9948x + 0.4345; R² = 0.9991
- The linear range of the system is 10-600 mg/dL.
Analytical Specificity (Interference Testing):
- No interference noted at therapeutic/physiological levels or specified test concentrations for most substances including Acetaminophen, Ascorbic Acid (levels ≤ 3.0 mg/dL), Cholesterol, Conjugated-Bilirubin, Creatinine, Dopamine, EDTA, Ephedrine, Ethanol, Fructose, Galatitol, Galactose, Gentisic acid, Glutathione (Reduced), Hemoglobin, Heparin Sodium, Ibuprofen, Isomalt, Lactitol, Lactose, L-Dopa, Maltitol, Maltose, Mannitol, Methyl Dopa, Paralidoxime Iododine (PAM), Salicylic Acid, Sodium, Sorbitol, Tetracycline, Tolazamide, Tolbutamide, Triglycerides, Unconjugated-Bilirubin, Urea, Uric Acid.
- Interference noted for Xylose at levels of 90 mg/dL and 200 mg/dL; NO INTERFERENCE at levels
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2018
ACON Laboratories, Inc. Qiyi Xie Senior Staff, Regulatory/Clinical Affairs 10125 Mesa Rim Road San Diego, CA 92121
Re: K181527
Trade/Device Name: On Call Sure Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: August 30, 2018 Received: August 31, 2018
Dear Qiyi Xie:
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/cfpmp/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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
Courtney H. Lias, Ph.D. for Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181527
Device Name
On Call Sure Blood Glucose Monitoring System
Indications for Use (Describe)
The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
| Type of Use (Select one or both, as applicable): |
|---|
| -------------------------------------------------- |
| For activities identified in 33 CFR 151.207, including lightering | In areas other than those identified in 33 CFR 151.207, including lightering |
|---|---|
| -------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K181527
Device Name
On Call Sure Sync Blood Glucose Monitoring System
Indications for Use (Describe)
The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
5. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is K181527.
Submitter's Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121
Tel.: 858-875-8011 Fax: 858-875-8019
Date Prepared: October 1, 2018
Contact Person:
Qiyi Xie Senior Officer, Clinical & Regulatory Affairs Email: qxie@aconlabs.com
Proprietary Name of the Device:
On Call Sure Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System
Common Name:
Glucose Test System
Classification Name:
Class II §862.1345 Glucose Test System
Predicate Device:
On Call Sharp Blood Glucose Monitoring System
ACON Laboratories, Inc. 10125 Mesa Rim Rd, San Diego, CA 92121
510(k) Number: K130284
Device Name: On Call Sure Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System
| Proprietary Name | Classification | Product
Code | Description | Common Name |
|-------------------------------------------------------------------------------------------|-------------------|-----------------|-----------------------------------------------------|------------------------|
| On Call Sure and
On Call Sure Sync
Blood Glucose
Monitoring System | 862.1345 Class II | NBW | System, Test,
Blood Glucose,
Over the Counter | Glucose Test
System |
5
Device Description:
The On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System are designed for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm
Both systems have almost the same meter design and use the same strip and control solution. The only difference is that On Call Sure Sync Blood Glucose meter is embedded with a Bluetooth module which results in an additional Bluetooth data transfer feature for this meter. Thus, the On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System can be considered equivalent for the performance of glucose testing.
Both systems share the same On Call Sure Blood Glucose test strip. It has a reagent system that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample to produce an electrical current signal. This current is measured using an amperometric detection method. The meter then calculates and displays the blood glucose concentration reading, calibrated to plasma reference. The On Call Sure / On Call Sure Sync Blood Glucose Meters are auto-coding.
Both systems consist of the On Call Sure / On Call Sure Sync Blood Glucose Meter, On Call Sure Blood Glucose Test Strips, and On Call Sure Clucose Control Solutions. Kits may be marketed with various combinations and quantities of the system components, or each of the components may be sold separately. All meter kits include a Carrying Case, User's Manual, Ouick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets.
The On Call Sure Glucose Control Solutions are used to confirm that the meter and test strips are working properly. Glucose control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. Two control solution levels are available (Level 1 and Level 2). Level 1 is provided with the system. Level 2 is sold separately.
Both meters have a USB data transfer function that is inactive, pending validation with the On Call Diabetes Management Software (K131469). Only the On Call Sure Sync Blood Glucose Meter is equipped with Bluetooth.
The On Call Sure Sync Blood Glucose Meter is designed with a Bluetooth module which can send glucose test results to a mobile device if the glucose meter and the mobile device are paired and within range.
6
Intended Use:
On Call Sure Blood Glucose Monitoring System
The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
On Call Sure Sync Blood Glucose Monitoring System
The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).
On Call Sure Test Strips
On Call Sure Test Strips are used with the On Call Sure Sync Blood Glucose Meters in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
On Call Sure Sync Glucose Control Solutions
On Call Sure Glucose Control Solutions are for use with the On Call Sure and On Call Sure Sync Blood Glucose Meters and Strips as a quality control check to confirm that the test strip and meter are working together properly, and that the user can perform the test correctly.
7
Technological Characteristics:
| On Call Sure | On Call Sure Sync | |
|---|---|---|
| System | Blood Glucose Meter | Blood Glucose Meter |
| Measurement Range | 40-600 mg/dL | Same |
| Test Time | 5 second | Same |
| Minimum Sample Size | 0.6 uL | Same |
| Coding | Auto Coding | Same |
| Hematocrit Range | 10-70% | Same |
| Insufficient Sample | Error message | Same |
| Control Recognition | Yes | Same |
| Strip Open Vial Stability | 6 months from first opening | Same |
| Strip Closed Vial Stability | 24 months (from DOM) | Same |
| Strip Storage Temperature | 2°C - 35°C (36° - 95 °F) | Same |
| Strip Storage Relative | ||
| Humidity | 10-90% R.H. | Same |
| Operating Temperature | 5°C - 45°C (41° - 113 °F) | Same |
| Operating Relative Humidity | 10-90% R.H. | Same |
| Precision | 250 mg/dL. The subject blood hematocrit range was 26-58%. |
Fingertip:
| Strip Lot | Slope | Intercept | R | R² | N | |
|---|---|---|---|---|---|---|
| 1790001 | Linear Regression | 0.9988 | -0.6583 | 0.9917 | 0.9836 | 122 |
| Lower 99% Confidence Interval | 0.9680 | -6.0381 | ||||
| Upper 99% Confidence Interval | 1.0297 | 4.7214 | ||||
| Strip Lot | Slope | Intercept | R | R² | N | |
| 1790002 | Linear Regression | 1.0155 | -3.1305 | 0.9914 | 0.9828 | 122 |
| Lower 99% Confidence Interval | 0.9834 | -9.0532 | ||||
| Upper 99% Confidence Interval | 1.0475 | 2.7923 | ||||
| Strip Lot | Slope | Intercept | R | R² | N | |
| 1790003 | Linear Regression | 1.0245 | -5.2398 | 0.9917 | 0.9834 | 122 |
| Lower 99% Confidence Interval | 0.9927 | -10.5395 | ||||
| Upper 99% Confidence Interval | 1.0563 | 0.0600 | ||||
| Strip Lot | All 3 Lots Linear Regression | Slope | Intercept | R | R² | N |
| All 3 Lots | Linear Regression | 1.0132 | -3.0677 | 0.9915 | 0.9831 | 366 |
| Lower 99% Confidence Interval | 0.9952 | -6.2246 | ||||
| Upper 99% Confidence Interval | 1.0312 | 0.0893 |
Summary of Linear Regression - Fingertip Site Measurement by Lay Users
20
Summary of User Evaluation System Accuracy in Tabular Format – Fingertip Site Measurement by Lay Users
| Finger Site | |||
|---|---|---|---|
| Lot 1790001 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 67 / 122 ( 54.9% ) | 109 / 122 ( 89.3% ) | 122 / 122 ( 100.0% ) | 122 / 122 ( 100.0% ) |
| Finger Site | |||
|---|---|---|---|
| Lot 1790002 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 68 / 122 ( 55.7% ) | 109 / 122 ( 89.3% ) | 121 / 122 ( 99.2% ) | 122 / 122 ( 100.0% ) |
| Finger Site | |||
|---|---|---|---|
| Lot 1790003 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 66 / 122 ( 54.1%) | 107 / 122 ( 87.7%) | 121 / 122 ( 99.2%) | 122 / 122 ( 100.0%) |
| Finger Site | |||
|---|---|---|---|
| All 3 Lots Combined | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 201 / 366 ( 54.9% ) | 325 / 366 ( 88.8% ) | 364 / 366 ( 99.5% ) | 366 / 366 ( 100.0% ) |
Summary of Linear Regression – Palm Site Measurement by Lay Users
| Strip Lot | Slope | Intercept | R | R2 | N | |
|---|---|---|---|---|---|---|
| 1790001 | Linear Regression | 1.0003 | -1.7710 | 0.9867 | 0.9735 | 122 |
| Lower 99% Confidence Interval | 0.9609 | -8.6405 | ||||
| Upper 99% Confidence Interval | 1.0397 | 5.0984 | ||||
| 1790002 | Linear Regression | 0.9722 | 1.1633 | 0.9907 | 0.9816 | 122 |
| Lower 99% Confidence Interval | 0.9404 | -4.7125 | ||||
| Upper 99% Confidence Interval | 1.0040 | 7.0392 | ||||
| 1790003 | Linear Regression | 0.9883 | -1.6537 | 0.9890 | 0.9781 | 122 |
| Lower 99% Confidence Interval | 0.9530 | -7.5432 | ||||
| Upper 99% Confidence Interval | 1.0237 | 4.2358 | ||||
| All 3 Lots | Linear Regression | 0.9851 | -0.4936 | 0.9889 | 0.9780 | 366 |
| Lower 99% Confidence Interval | 0.9650 | -4.0130 | ||||
| Upper 99% Confidence Interval | 1.0052 | 3.0259 |
21
| Palm Site | |||
|---|---|---|---|
| Lot 1790001 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 63 / 122 ( 51.6% ) | 104 / 122 ( 85.2% ) | 121 / 122 ( 99.2% ) | 122 / 122 ( 100.0% ) |
Summary of System Accuracy in Tabular Format – Palm Site Measurement by Lay Users
| Palm Site | |||
|---|---|---|---|
| Lot 1790002 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 63 / 122 ( 51.6%) | 103 / 122 ( 84.4%) | 121 / 122 ( 99.2%) | 122 / 122 ( 100.0%) |
| Palm Site | |||
| Lot 1790003 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 62 / 122 ( 50.8% ) | 102 / 122 ( 83.6% ) | 120 / 122 ( 98.4% ) | 122 / 122 ( 100.0% ) |
| Palm Site | |||
|---|---|---|---|
| All 3 Lots Combined | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 188 / 366 ( 51.4% ) | 309 / 366 ( 84.4% ) | 362 / 366 ( 98.9% ) | 366 / 366 ( 100.0% ) |
Summary of Linear Regression – Forearm Site Measurement by Lay Users
| Strip Lot | Slope | Intercept | R | R² | N | |
|---|---|---|---|---|---|---|
| 1790001 | Linear Regression | 1.0086 | -0.3791 | 0.9889 | 0.9779 | 122 |
| Lower 99% Confidence Interval | 0.9724 | -6.6891 | ||||
| Upper 99% Confidence Interval | 1.0448 | 5.9308 | ||||
| 1790002 | Linear Regression | 0.9822 | 3.5869 | 0.9895 | 0.9791 | 122 |
| Lower 99% Confidence Interval | 0.9480 | -2.7368 | ||||
| Upper 99% Confidence Interval | 1.0165 | 9.9106 | ||||
| 1790003 | Linear Regression | 0.9993 | 1.2168 | 0.9863 | 0.9728 | 122 |
| Lower 99% Confidence Interval | 0.9593 | -5.4384 | ||||
| Upper 99% Confidence Interval | 1.0392 | 7.8721 | ||||
| All 3 Lots | Linear Regression | 0.9946 | 1.7728 | 0.9884 | 0.9770 | 366 |
| Lower 99% Confidence Interval | 0.9739 | -1.8616 | ||||
| Upper 99% Confidence Interval | 1.0154 | 5.4071 |
22
Summary of User Evaluation System Accuracy in Tabular Format - Forearm Site Measurement by Lav Users
| Forearm Site | |||
|---|---|---|---|
| Lot 1790001 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 61 / 122 ( 50.0%) | 101 / 122 ( 82.8%) | 120 / 122 ( 98.4%) | 122 / 122 (100.0%) |
| Forearm Site | |||
| Lot 1790002 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 59 / 122 (48.4%) | 100 / 122 ( 82.0%) | 119 / 122 (97.5%) | 122 / 122 ( 100.0%) |
| Forearm Site | |||
| Lot 1790003 |
| ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | |||
|---|---|---|---|
| Lot 1790003 | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 60 / 122 ( 49.2% ) 102 / 122 ( 83.6% ) 20 / 122 ( 98.4% ) 22 / 122 ( 100.0% ) | |||
| Forearm Site | |||
| All 3 Lots Combined | |||
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 180 / 366 ( 49.2% ) | 303 / 366 ( 82.8% ) | 359 / 366 ( 98.1% ) | 366 / 366 ( 100.0% ) |
Part I Conclusion (User Evaluation Study)
The results of the study passed the acceptance criteria that 95% of all SMBG results are within 15% of the comparator results across the entire claimed measuring range of the device, and that 99% of all SMBG results are within 20% of the comparator results across the entire claimed measuring range for the device.
Part II:
Accuracy at Extreme Glucose Values Study
Based on "FDA Guidance for Industry and Food and Drug Administration Staff-Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016)," the accuracy at the extreme upper and lower ends of the claimed measuring range were assessed using capillary blood samples obtained from subjects in the user evaluation study. Capillary blood samples (n=149) were saved and used for the accuracy at extreme glucose values study. 88 capillary blood samples were glycolyzed at room temperature to obtain glucose concentrations 250 mg/dL. Each contrived blood sample was measured with the SMBG in duplicate for each lot.
23
Results relative to YSI:
Summary of Accuracy at Extreme Glucose Values Study - Tabular Data Format
Low Glucose Level: 40 - 80 mg/dL, First Measurement Only Accuracy at Extreme Glucose Value by Absolute Bias - Low
| On Call Sure/On Call Sure Sync BGMS - Accuracy at Extreme Glucose Values | ||||
|---|---|---|---|---|
| Glucose concentrations ≤ 80 mg/dL | ||||
| Lot | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | Within ± 20 mg/dL |
| 1790001 | 63 / 88 ( 71.6% ) | 88 / 88 ( 100.0% ) | 88 / 88 ( 100.0% ) | 88 / 88 ( 100.0% ) |
| 1790002 | 70 / 88 ( 79.5% ) | 88 / 88 ( 100.0% ) | 88 / 88 ( 100.0% ) | 88 / 88 ( 100.0% ) |
| 1790003 | 66 / 88 ( 75.0% ) | 88 / 88 ( 100.0% ) | 88 / 88 ( 100.0% ) | 88 / 88 ( 100.0% ) |
| All 3 Lots | 199 / 264 ( 75.4% ) | 264 / 264 ( 100.0% ) | 264 / 264 ( 100.0% ) | 264 / 264 ( 100.0% ) |
High Glucose Level: 250 - 600 mg/dL, First Measurement Only Accuracy at Extreme Glucose Value by % Bias - High
| On Call Sure/On Call Sure Sync BGMS - Accuracy at Extreme Glucose Values | ||||
|---|---|---|---|---|
| Glucose concentrations ≥ 250 mg/dL | ||||
| Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 1790001 | 43 / 61 ( 70.5% ) | 58 / 61 ( 95.1% ) | 61 / 61 ( 100.0% ) | 61 / 61 ( 100.0% ) |
| 1790002 | 40 / 61 ( 65.6% ) | 55 / 61 ( 90.2% ) | 61 / 61 ( 100.0% ) | 61 / 61 ( 100.0% ) |
| 1790003 | 41 / 61 ( 67.2% ) | 58 / 61 ( 95.1% ) | 61 / 61 ( 100.0% ) | 61 / 61 ( 100.0% ) |
| All 3 Lots | 124 / 183 ( 67.8% ) | 171 / 183 ( 93.4% ) | 183 / 183 ( 100.0% ) | 183 / 183 ( 100.0% ) |
Part II Conclusion (Accuracy at Extreme Glucose Values Study)
The results of the study passed the acceptance criteria that 95% of all SMBG results are within 15% of the comparator results across the entire claimed measuring range of the device, and that 99% of all SMBG results are with 20% of the comparator results across the entire claimed measuring range for the device.
Overall Conclusions:
The results of the study demonstrated that the On Call Sure Sync Blood Glucose Monitoring System is accurate in the claimed measuring range using finger capillary blood samples obtained from subjects, based upon both the user evaluation and the extreme glucose values study.