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The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.

Here's a breakdown of the acceptance criteria and the study that demonstrates the GlucoPlus device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list. Instead, it presents system accuracy results, which are essentially the performance metrics against which the device's accuracy is judged. For blood glucose meters, these typically involve how close the meter's reading is to a reference method (like YSI). The FDA guidance for blood glucose meters at the time (though not explicitly cited as such here) often referenced ISO 15197 for system accuracy.

Here's an interpretation of the implied acceptance criteria from the "System accuracy results" section and the reported performance:

Note: While the document presents these results, it doesn't explicitly state what percentage within each range would constitute "acceptance." However, the strong correlation (R > 0.98) and the overall system accuracy results, particularly 100% within 15 mg/dL for low glucose and 93% within ±15% for high glucose (with 98.8% within ±20%), are generally indicative of acceptable performance for blood glucose monitoring systems at the time of this submission. The FDA's clearance implies these results met their criteria.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size:

  • Consumer Study (Lay Users): N = 120 specimens
  • Consumer Study (Technician): N = 120 specimens
  • Point of Care Study: N = 200 specimens (broken down as: Home Medical (58), Metabolism (62), Internal (80))
  • System Accuracy: Based on the detailed breakdown: 28 measurements for glucose < 75 mg/dL and 172 measurements for glucose ≥ 75 mg/dL, totaling 200 measurements. This likely corresponds to the "Point of Care Study" total or a combined analysis of all samples against the YSI reference.

• Data Provenance: The studies explicitly state "using capillary whole blood on clinical centers." This indicates prospective data collection within a clinical setting. The country of origin is not explicitly stated, but the sponsor's address is Quebec, Canada, and the FDA is in the USA, suggesting North American involvement.

3. Number of Experts and their Qualifications for Ground Truth:

The document does not specify the number of "experts" used to establish the ground truth. The ground truth was established by laboratory reference instruments, which are operated by trained laboratory personnel (technicians) rather than clinical experts in the sense of physicians or radiologists.

4. Adjudication Method:

This is not applicable as the ground truth was established by laboratory reference instruments (YSI). There was no human "adjudication" necessary between experts.

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 is typically associated with imaging devices where human readers interpret images, sometimes with and without AI assistance. For a blood glucose meter, the primary evaluation is the device's accuracy against a gold standard reference, not how it improves human interpretation.

6. Standalone Performance Study (Algorithm Only):

Yes, a standalone performance study was done. The "Consumer Study" and "Point of Care Study" directly evaluate the GlucoPlus device's readings against a laboratory reference method (YSI), which represents its standalone performance without human input influencing the measurement itself. The user collects the sample and operates the device, but the measurement algorithm is the focus of these studies.

7. Type of Ground Truth Used:

The ground truth used was laboratory reference method (YSI). The YSI (Yellow Springs Instruments) analyzer is widely considered a gold standard for blood glucose measurement in laboratory settings due to its high accuracy.

8. Sample Size for the Training Set:

The document does not provide any information about a specific training set or its sample size. This type of information is often more relevant for AI/machine learning models where a large dataset is used to "train" the algorithm before testing. For a device like a blood glucose meter (especially from 2006), the "algorithm" is typically a predefined electrochemical calculation, not a learned model from a large training dataset in the modern AI sense. The development likely involved calibration and engineering optimization rather than distinct "training" and "test" sets of patient data.

9. How Ground Truth for Training Set was Established:

As no training set is mentioned (see point 8), the method for establishing its ground truth is also not provided.

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