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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).

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.

AI/ML Overview

The acceptance criteria and study proving the device meets them are detailed below based on the provided FDA 510(k) summary. The device in question is the ACON Laboratories, Inc. On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against the FDA Guidance for Industry and Food and Drug Administration Staff - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016) regarding accuracy. The acceptance criteria for glucose meters typically follow an established standard, in this case, a combination of ISO 15197:2015 and FDA guidance.

Acceptance Criteria (FDA Guidance 2016)	Reported Device Performance (On Call Sure Sync BGMS) - User Evaluation Study (All 3 Lots Combined Capillary Blood Samples)	Reported Device Performance (On Call Sure Sync BGMS) - Accuracy at Extreme Glucose Values Study (All 3 Lots Combined Capillary Blood Samples)
**For glucose concentrations 95% of results within ± 15 mg/dL of comparator		100.0% within ± 15 mg/dL (264/264)
>99% of results within ± 20 mg/dL of comparator		100.0% within ± 20 mg/dL (264/264)
For glucose concentrations ≥ 80 mg/dL:		High Glucose Level (250-600 mg/dL):
>95% of results within ± 15% of comparator	Fingertip: 99.5% within ± 15% (364/366)
Palm: 98.9% within ± 15% (362/366)
Forearm: 98.1% within ± 15% (359/366)	93.4% within ± 10% (171/183)
100.0% within ± 15% (183/183)
>99% of results within ± 20% of comparator	Fingertip: 100.0% within ± 20% (366/366)
Palm: 100.0% within ± 20% (366/366)
Forearm: 100.0% within ± 20% (366/366)	100.0% within ± 20% (183/183)
Overall Acceptance Criteria: 95% of all SMBG results are within 15% (or 15 mg/dL for 250 mg/dL. Each contrived sample was measured in duplicate for each of the 3 lots, resulting in:

    *   Low Glucose: 88 samples * 3 lots = 264 measurements
    *   High Glucose: 61 samples * 3 lots = 183 measurements

Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA, implying they were performed for regulatory approval purposes. While the specific country of origin for the study participants is not explicitly stated, the submission is from ACON Laboratories, Inc., located in San Diego, California, USA, and follows FDA guidance, suggesting the studies were likely conducted in the United States or under similar clinical regulatory standards. The studies were prospective in nature, involving active recruitment of subjects to use the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth reference method used was the YSI Model 2300 STAT PLUS Glucose Analyzer (K913806).
The document states that the YSI 2300 glucose measurement results were obtained by trained technicians. No specific number of experts (technicians) is provided, nor are their detailed qualifications (e.g., years of experience). The YSI 2300 STAT PLUS is a laboratory-grade reference instrument often used for establishing ground truth in glucose monitoring studies.

4. Adjudication Method for the Test Set

For the user evaluation study, the trained technician collected capillary blood samples in microtainer tubes (with heparin anticoagulant) to be measured on the YSI 2300 Stat Plus Glucose Analyzer in duplicate. This duplicate measurement likely served as an internal check for the reference method, but there is no explicit mention of an adjudication method used to resolve discrepancies between device readings and the reference, or between multiple reference measurements, beyond the duplicate testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Readers Improve with AI vs. Without AI Assistance)

This device is a blood glucose monitoring system intended for self-testing by individuals with diabetes. It is a standalone analytical instrument and does not involve "human readers" interpreting medical images or data assisted by AI for diagnosis. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The studies focused on the accuracy of the device itself when used by lay persons compared to a laboratory reference.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation (algorithm only, in the sense of the device's internal measurement and calculation) was a core component of the non-clinical testing. This included:
- Precision/Reproducibility: Repeatability and Intermediate Precision studies were conducted using the device on venous blood samples and control solutions.
- Linearity/Assay Reportable Range: Evaluated the device's ability to accurately measure glucose across its claimed range using prepared blood samples.
- Analytical Specificity (Interference): Tested the device's accuracy in the presence of various interfering substances.
- Stability, Detection Limit, Hematocrit Effect, Temperature Effect, Altitude Effect, Sample Volume, Humidity Effect, etc.: These are all tests of the device's inherent analytical performance without direct human interpretation of results beyond performing the test procedure.
The "User Evaluation Study" involved lay persons operating the device, but the focus was on the system accuracy (device + user) compared to the reference, rather than an "algorithm-only" performance in isolation from user impact.

7. The Type of Ground Truth Used

The ground truth used for both the user evaluation study and the accuracy at extreme glucose values study was a laboratory reference method: the YSI Model 2300 STAT PLUS Glucose Analyzer. This is a widely accepted standard for determining glucose concentrations in blood samples.

8. The Sample Size for the Training Set

This document is a 510(k) summary for a traditional blood glucose meter, not an AI/ML-driven device that typically relies on large "training sets" in the same way. The device's measurement principles are based on established electrochemical enzymatic assays. Any internal calibration or algorithm development would likely have been performed using laboratory data during the device's development phase, but specific "training set" sizes are not applicable/provided in the context of this traditional device submission.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" in the context of AI/ML is not applicable here. For the device's internal calibration and analytical performance development (if a similar term were to be used), the ground truth for establishing values (e.g., for control solutions) was determined by an in-house procedure using the YSI reference method. The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System is also stated to be traceable to the NIST SRM 917b reference material.

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