(70 days)
The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System is an over-the-counter (OTC) home test for glucose in blood. The system is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System can be used with capillary and venous blood specimens, arterial blood specimens and neonatal blood specimens.
The GLUCOMETER ENCORE QA+ Blood Glucose Meter is part of the GLUCOMETER ENCORE Blood Glucose Monitoring System. The GLUCOMETER ENCORE Blood Glucose Monitoring System is an over-the-counter home testing system for measuring glucose in blood. The System is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The GLUCOMETER ENCORE QA+ Blood Glucose Meter is a reflectance photometer used with GLUCOMETER ENCORE® Blood Glucose Test Strips to determine the glucose concentration in whole blood. The modified instrument minimizes the optical and chemical interferences of hemoglobin with the test strips. Accurate results can be obtained at hematocrit levels and glucose levels that are seen in neonatal populations.
The provided text describes the GLUCOMETER ENCORE® QA+ Blood Glucose Meter (Neonatal Modification). While it states that the device's performance was evaluated, it does not provide specific acceptance criteria or detailed results of the study in a quantitative manner. Therefore, I will respond to the extent the information is available in the provided text.
Here's an analysis based on the given information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the GLUCOMETER ENCORE® QA+ Blood Glucose Meter (Neonatal Modification). However, it broadly states that:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate devices | "demonstrated that the device is equivalent in performance to the predicate devices" |
| Suitability for neonatal blood specimens | "suitable for use with neonatal blood specimens" |
| Good performance in comparison to clinical laboratory blood glucose analyzers | "results of the studies demonstrated good performance in comparison to clinical laboratory blood glucose analyzers." |
2. Sample size used for the test set and the data provenance
The document states, "The performance of the GLUCOMETER ENCORE QA+ Blood Glucose Meter (Neonatal Modification) was evaluated in studies inhouse and in healthcare facilities with neonatal blood specimens."
- Sample Size: Not specified.
- Data Provenance: The studies were conducted "inhouse and in healthcare facilities" and used "neonatal blood specimens." The country of origin is not explicitly stated, but the submission is to the US FDA, implying studies might have taken place in the US or according to US regulatory standards. The studies were likely prospective, given they were "evaluating" the performance of the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document only mentions comparison to "clinical laboratory blood glucose analyzers" for performance evaluation, implying these analyzers served as a reference.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified.
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
Not applicable. This device is a blood glucose meter, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study focused on the standalone performance of the GLUCOMETER ENCORE® QA+ Blood Glucose Meter (Neonatal Modification) itself. The device is intended for direct measurement of blood glucose, so its performance is inherently standalone in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth or reference standard was established by "clinical laboratory blood glucose analyzers." This indicates a comparison against established, high-accuracy laboratory methods for measuring blood glucose.
8. The sample size for the training set
Not applicable. The document describes a performance evaluation of a device, not the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set for an AI algorithm.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.