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The On Call® Express Pro 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 Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.

The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).

The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Control Solution is for use with the On Call® Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

The On Call Express Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The On Call Express Pro Blood Glucose Monitoring System contains a blood glucose meter and On Call Express Pro blood glucose test strips. This is a no code meter. The On Call Express Pro Blood Glucose Monitoring System consists of the On Call Express Pro Blood Glucose Meter, On Call Express Pro Blood Glucose control solutions (Level 1 and Level 2), Carrying Case, User's Manual, Warranty Card and Logbook. Materials needed but not provided are the On Call Express Pro Blood Glucose Test strips and disposable, single use lancing devices.

Control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. The products are intended for use to verify the performance of the On Call Express Pro Blood Glucose Monitoring System

On Call Express Pro Blood Glucose Monitoring System has a data transfer function.

Data Port sends information to a computer via an optional data transfer cable. It allows users to view, analyze and print stored data in the meter. The data transfer cable is available for order as an optional add-on. The meter can transfer stored test results to a Windows-based personal computer (PC) using an optional data transfer cable and the On Call® Diabetes Management Software (K131469). The software has been validated for use with On Call Express meter (K132086) which is the exact same device as On Call Express Pro meter.

Here's a summary of the acceptance criteria and the study details for the On Call® Express Pro Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems are generally outlined in ISO 15197:2013. While the document doesn't explicitly state the acceptance criteria thresholds (e.g., specific percentages for each glucose range), it reports the device's performance against typical accuracy categories. The FDA guidance mentioned ("FDA Guidance for Industry In-Vitro Diagnostic Glucose Test System") would also refer to these standards.

Below is a combined table showing the reported device performance for both the Method Comparison Study (Healthcare Professionals) and the User Performance Study (Lay Persons). The implicit acceptance criteria are that the device performance meets or exceeds these reported percentages, aligning with regulatory standards for glucose meters.

Method Comparison Study (Healthcare Professionals)

User Performance Study (Lay Persons)

2. Sample Size for the Test Set and Data Provenance

• Sample Size:
  • Method Comparison Study (Healthcare Professionals): 103 natural capillary blood samples + 8 altered samples (total 111 samples) for each of the three body sites (fingertip, forearm, palm).
  • User Performance Study (Lay Persons): 103 study subjects. Each subject likely provided samples from fingertip, forearm, and palm.
• Data Provenance: The studies were conducted as "clinical studies" and "laboratory performance testing." The text does not specify the country of origin but implies a prospective collection as part of the regulatory submission process. It does not mention retrospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Ground Truth Establishment: The ground truth for glucose measurements was established using the YSI Model 2300 STAT PLUS (K913806) analyzer as the reference method.
• Experts and Qualifications: The document mentions "healthcare professionals" performed the method comparison study. It does not specify the number of individual experts or their specific qualifications (e.g., radiologist with X years of experience), as the "expert" here is primarily the reference instrument (YSI analyzer) and the trained personnel operating it.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for disagreements among human readers or device results. The reference method (YSI analyzer) is considered the definitive ground truth, so there is no need for human adjudication in the context of comparing the device to this gold standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or data with and without AI assistance to measure the effect size of AI. The On Call Express Pro Blood Glucose Monitoring System is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire set of "Laboratory Performance Testing" (precision, linearity, interference, stability, etc.) and the "Method Comparison Study" directly evaluate the performance of the device itself (algorithm only, in the sense of the meter's internal calculations, without human interpretation for diagnosis). The "User Performance Study" also evaluates the device's performance when operated by lay users, which is still a standalone measurement by the device, just with a different operator.

7. Type of Ground Truth Used

• The ground truth used was primarily a reference method (YSI Model 2300 STAT PLUS analyzer) for quantitative glucose measurement. This is a highly accurate laboratory instrument often considered a gold standard for glucose testing.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. The studies described (precision, linearity, method comparison, user performance) are typically validation or verification studies, performed on the finalized device. The training data for the device's internal algorithms (e.g., for calibrating the meter and test strip system) would have been used during the development phase, but details on that are not provided in this regulatory summary.

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

• As mentioned in point 8, information on the training set is not provided. However, for a device like this, the establishment of ground truth for training data would typically involve:
  • Using high-precision laboratory reference methods (similar to the YSI analyzer used for validation).
  • Precisely prepared glucose solutions of known concentrations.
  • Rigorous calibration against NIST traceable standards (as mentioned in the "Traceability" section, "The On Call Express Pro Blood Glucose Monitoring System is traceable to the NIST SRM 917b reference material").
  • Controlled experiments to characterize the electrochemical reaction and translate electrical signals to glucose concentrations.

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