(98 days)
The GLUCOMETER® DEX® 2 Blood Glucose Meter and the GLUCOMETER® DEX® Test Sensors are used to measure the glucose levels in whole blood from specimens taken from the fingers or an alternate puncture sites within cartain conditions. The GLUCOMETER® DEX® Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The GLUCOMETER® DEX® Diabetes Care System includes: GLUCOMETER® DEX® 2 Blood Glucose Meter GLUCOMTER® DEX® Test Sensors This Diabetes Care System consists of an electrochemical methodbased meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
The provided text describes the GLUCOMETER® DEX® Diabetes Care System, an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing blood glucose. The submission states that the device is conceptually the same as other blood glucose monitoring products. The acceptance criteria and the study conducted are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The device can produce blood glucose results from alternate puncture sites that are equivalent to blood glucose results from fingersticks within certain conditions explained in product labeling. | The studies demonstrated that users can obtain blood glucose results from alternate puncture sites that are equivalent to blood glucose results from fingersticks within certain conditions. |
| The System has a linear response to glucose from 10-600 mg/dL. | The System has a linear response to glucose from 10-600 mg/dL. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the summary mentions "an evaluation... conducted in a clinical setting by persons with diabetes." It does not provide specific numbers for participants or tests performed.
- Data Provenance: The study was conducted in a "clinical setting." No specific country of origin is mentioned, but the submitter is based in Elkhart, IN, USA. The study appears to be a prospective clinical evaluation as it involves actual users, "persons with diabetes," and healthcare professionals using the device in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. The "ground truth" seems to be established by comparison with "blood glucose results from fingersticks," implying a reference method, but the qualifications of individuals performing or interpreting these reference tests are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described focuses on the equivalence of alternate puncture site results to fingerstick results, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a blood glucose meter system used by individuals with diabetes or healthcare professionals. Therefore, its performance intrinsically involves "human-in-the-loop." A standalone algorithm-only performance study, as typically understood for imaging or diagnostic algorithms, is not applicable or described for this type of device. The "performance" refers to the accuracy of the device itself in measuring glucose.
7. Type of Ground Truth Used
The ground truth used for comparison was "blood glucose results from fingersticks." This implies that fingerstick blood glucose measurements, likely obtained using a recognized reference method or another validated blood glucose meter, served as the standard against which alternate puncture site measurements were compared.
8. Sample Size for the Training Set
This information is not applicable. The GLUCOMETER® DEX® Diabetes Care System is described as an "electrochemical method-based meter" employing an "amperometric glucose oxidase method." This is a biochemical measurement system, not a machine learning or AI-driven device that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no mention of a training set for an AI/machine learning model. The device's underlying technology is based on electrochemical principles.
§ 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.