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The On Call® Chosen Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Chosen Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.

The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

The On Call Chosen Blood Glucose Control Solution is for use with the On Call Chosen Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The On Call "Chosen 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. This 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.

This document describes the acceptance criteria and the study performed for the On Call Chosen Blood Glucose Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The submission references compliance with EN ISO 15197:2003 for accuracy requirements. Based on the "Discussion of Clinical Tests Performed" section, it states that the system meets these accuracy requirements. No specific performance metrics (e.g., bias, CV, or percentages within zones of an error grid) are numerically presented in the provided text as 'acceptance criteria' vs. 'reported performance' in a direct comparison table. However, the overall conclusion states that the device meets the accuracy requirements per EN ISO 15197.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies were conducted with lay persons and trained laboratory technicians," but does not provide the number of participants or samples collected.
• Data Provenance: Not explicitly stated. Given ACON Laboratories, Inc. is located in San Diego, California, it's likely the studies were conducted in the US, but this is not confirmed. The study was conducted according to the "ACON Clinical Study Protocol for the Blood Glucose Monitoring System," implying a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts/Ground Truth Method: The reference method for establishing ground truth was the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade analyzer for glucose measurement, not an expert human assessment.
• Qualifications of Experts: Not applicable, as the ground truth was established by an analytical instrument. However, the study involved "trained laboratory technicians" who operated the YSI device, implying they were qualified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The ground truth was established by a reference instrument (YSI Model 2300 STAT PLUS). No human adjudication process is mentioned for the reference method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a blood glucose monitoring system, and the study focused on its accuracy compared to an established laboratory reference, and ease of use by lay persons, rather than assessing improvements in human reader performance with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, in essence, the "system accuracy" evaluation of the On Call Chosen Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS constitutes a standalone performance evaluation of the device itself (though humans are involved in using both systems). The study specifically aimed to show that "nonprofessional, inexperienced lay persons were able to obtain comparable blood glucose readings" to those obtained by trained technicians using the reference, implying the device's inherent accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth was established using a reference laboratory instrument, specifically the YSI Model 2300 STAT PLUS (K913806).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is a blood glucose monitoring system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The studies performed were for verification and validation of the device's performance, not for training an algorithm.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device mentioned.

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