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The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).

SuperCheck Pro Blood Glucose Monitoring System is used for determining the approximate concentration of glucose in the blood. A complete kit (starter kit) of SuperCheck Pro Blood Glucose Monitoring System consists of:

• 1. SuperCheck Pro Blood Glucose Meter
• 2. SuperCheck Pro Blood Glucose Test Strips
• 3. OKmeter Control Solution (Level I, II)

Before use, The SuperCheck Pro Blood Glucose Test Strips should be inserted into the SuperCheck Pro Blood Glucose Meter first. Prick a fingertip with a sterile Lancet that installed in the Lancing device and apply the blood drop to the front edge of the Test Strip. Wait for 5 seconds and the Meter will display the test result.

OKmeter Control Solution containing a known amount of glucose that is used to confirm SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips are working properly together. Follow the same steps as above but replace the blood drop by OKmeter Control Solution.

OKmeter Control Solution and SuperCheck Pro Blood Glucose Test Strips could be separately bought.

The SuperCheck Pro Blood Glucose Monitoring System (Model OK-2MJB) measures the amounts of glucose in whole blood quantitative using fresh capillary whole blood from the fingertip and alternative sites including palm, forearm, upper arm, calf, and thigh. Amperometric technology is used for the detection of glucose from the strip with whole blood sample on the meter. Reagent consisting of glucose dehydrogenase with its cofactor flavin adenine dinucleotide (GDH-FAD) and mediator is deposited onto the reaction area of the test strip with carbon printed electrodes. The testing is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose with the enzyme, GDH-FAD, on the test strip. The meter measures the strength of the current which is proportional to the amounts of glucose in the sample and displays the corresponding blood glucose concentration.

The provided text describes the SuperCheck Pro Blood Glucose Monitoring System and its substantial equivalence to a predicate device. It includes information on the device's indications for use, description, test principle, and a comparison with the predicate device. The document also summarizes non-clinical and clinical testing performed. However, it does not explicitly detail acceptance criteria with reported device performance in a numerical format, nor does it provide specific information regarding sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details.

Based on the available text, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states that "all performance criteria were met" for both non-clinical and clinical studies. However, the specific numerical acceptance criteria for performance and the reported device performance values are not provided in the text. For example, for precision, linearity, or accuracy, the target ranges or thresholds and the actual measured performance are not listed.

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

The text mentions "Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use..." but does not provide details on the sample size (number of participants) for this user evaluation or any other clinical study. The data provenance (country of origin, retrospective/prospective) is also not specified.

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)

This information is not provided in the text.

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

This information is not provided in the text.

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

This is not applicable as the device is a Blood Glucose Monitoring System, which does not involve human readers interpreting cases with or without AI assistance.

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

The device is a blood glucose monitoring system intended for self-testing. Its performance is inherently standalone (algorithm/device only) in the context of generating a blood glucose measurement. The "Clinical Testing Summary" mentions "A user evaluation confirmed the system accuracy, operation according to design, and ease of use," implying human interaction for using the device, but the core measurement is a standalone function of the device. The text does not provide specific performance metrics for this standalone function, only that "all performance criteria were met."

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

For a blood glucose monitoring system, the ground truth for accuracy would typically be established against a laboratory reference method (e.g., a laboratory analyzer that measures blood glucose). The document does not explicitly state the specific reference method used, but it is implied that the system's measurements were compared against accepted standards to confirm accuracy.

8. The sample size for the training set

This information is not applicable because this device is not an AI/ML device that requires a training set in the typical sense. It's a hardware-based electrochemical sensor system.

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

This information is not applicable for the reasons stated above.

Summary of available information related to acceptance criteria and study:

The submission confirms that non-clinical and clinical studies were conducted to test, verify, and validate the performance of the proposed device according to FDA Guidance issued on September 29, 2020: "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and other relevant standards. The crucial statement is: "Results from these studies show that all performance criteria were met."

Non-Clinical Testing Summary: Design verification and validation testing included electrical/mechanical safety tests, functional performance tests (precision, linearity, interference, flex studies) as well as disinfection, cleaning, and robustness studies. Software validation was also performed.

Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use.

While the document states that all criteria were met and lists the types of tests performed, it lacks the specific quantitative details of the acceptance criteria and the measured performance results for each.

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