(130 days)
The GLUCOMETER ELITE Blood Glucose Test Systems are used for self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.
The GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professional in home settings and in healthcare facilities. The GLUCOMETER ELITE Blood Glucose Test Strips are for use with the GLUCOMETER ELITE Blood Glucose Test family of meters.
The GLUCOMETER ELITE and the GLUCOMETER ELITE XL Blood Glucose Meters are specific for glucose and have been referenced to give plasmalserum equivalent glucose results. The test systems provide a quantitative measurement of glucose in whole blood from 10 - 600 mg/dL (0.6 to 33.3 mmol/L). In addition, both the GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER XL Blood Glucose Meter can be used with arterial blood specimens. The GLUCOMETER XL Blood Glucose Meter can be used with neonatal specimens.
The GLUCOMETER ELITE Blood Glucose Test Strips are based on the measurement of electrical potential caused by the reaction of glucose with the reagents (Glucose Oxidase method) on the electrode of the strip.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Glucometer® Elite® Blood Glucose Test Systems:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria (e.g., "accuracy should be within +/- X% of reference method Y"). Instead, it focuses on demonstrating suitability for expanded use cases.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable for intended use with neonatal specimens (GLUCOMETER ELITE XL) | "The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for neonatal... specimens" (Section 1) |
| Suitable for intended use with arterial specimens (GLUCOMETER ELITE XL) | "The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for... arterial specimens" (Section 1) |
| Suitable for intended use with arterial specimens (GLUCOMETER ELITE) | "a separate clinical study was conducted to likewise demonstrate the efficacy of the GLUCOMETER ELITE Blood Glucose Test Systems for use with arterial samples." and "the GLUCOMETER ELITE Blood Glucose Test Systems use of arterial specimens are suitable for its intended use." (Section 1) |
| Quantitative measurement of glucose in whole blood | "The test systems provide a quantitative measurement of glucose in whole blood from 10 - 600 mg/dL (0.6 to 33.3 mmol/L)." (Section 1) |
2. Sample Size Used for the Test Set and Data Provenance
The text states that evaluations were "conducted at four clinical sites" and a "separate clinical study was conducted." However, it does not provide specific sample sizes for the test set(s) or the country of origin of the data. Given the "Conclusion" statement and the nature of medical device submissions, it is highly likely that these were prospective studies since they were conducted to demonstrate performance for expanded indications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. For a blood glucose meter, ground truth is typically established using a highly accurate laboratory reference method, not necessarily by expert consensus in a subjective sense.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for a test set. This is not typically relevant for quantitative measurements like blood glucose, where a reference laboratory method provides the "truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is primarily relevant for imaging diagnostics where human interpretation is a key component, often assisted by AI. The Glucometer® is a direct measurement device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was conducted. The studies described evaluating the "GLUCOMETER ELITE XL Blood Glucose Meter" and the "GLUCOMETER ELITE Blood Glucose Test Systems" without any mention of human-in-the-loop assistance. The device itself performs the measurement.
7. The Type of Ground Truth Used
The type of ground truth used would have been a laboratory reference method for glucose measurement, which is the standard for validating blood glucose meters. The text implies this by stating the device is "referenced to give plasma/serum equivalent glucose results," indicating comparison to a recognized gold standard.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. For a device like a blood glucose meter, there isn't typically a "training set" in the machine learning sense. Performance is assessed against known reference values, and the device's chemical-electrical design determines its accuracy, not an algorithm "trained" on data for an initial release.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of this device's submission, there is no information on how its ground truth was established.
§ 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.