(58 days)
The GLUCOMETER® DEX® TEST SENSOR is used with the GLUCOMETER® DEX® and GLUCOMETER® DEX®2 Blood Glucose Meters to measure the glucose level in whole blood. The GLUCOMETER® DEX Blood Glucose System is a home use (OTC) device used by persons with diabetes, and by health care professionals in clinical settings for the selfmonitoring of blood glucose as an adjunct to the care of persons with diabetes.
The GLUCOMETER ® DEX® Test Sensor (modified) is for use with the GLUCOMETER® DEX® family of Blood Glucose Meters. The GLUCOMETER DEX Blood Glucose Test System is an over-the-counter (OTC) home test for glucose in blood. The system is used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
Here's an analysis of the provided text regarding the GLUCOMETER® DEX® TEST SENSOR, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K012205) is a 510(k) Safety and Effectiveness Summary. It does not explicitly state numerical acceptance criteria in terms of accuracy metrics (e.g., specific MARD or percentage agreement targets relative to a reference method) that are typical for blood glucose meters. Instead, it describes general performance assessment and suitability for intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable for intended use | "The studies demonstrated that the GLUCOMETER® DEX® Test Sensor (modified) is suitable for its intended use." |
| Satisfactory performance | "The results of the evaluation of the GLUCOMETER® DEX® Test Sensor (modified) demonstrate satisfactory performance..." |
| Linear response to glucose | "...linear response to glucose from 10-600 mg/dL." |
| Referenced to plasma glucose | "Blood glucose results are referenced to plasma glucose." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of participants or samples used in the clinical studies. It vaguely states: "The performance of the GLUCOMETER® DEX® Test Sensor (modified) was studied in both in-house and clinical settings by healthcare professionals and by persons with diabetes."
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address (Elkhart, IN, USA) and the FDA approval process, it is highly likely the studies were conducted in the United States. The studies were a mix of in-house and clinical settings. The phrase "was studied... by persons with diabetes" implies prospective clinical studies involving intended users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their specific qualifications for establishing ground truth. It mentions that performance was assessed "by healthcare professionals and by persons with diabetes," but it doesn't elaborate on the "ground truth" reference method or the personnel involved in its establishment. For blood glucose meters, ground truth is typically established by laboratory reference methods, not subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable. This device is a blood glucose sensor, and its performance is typically evaluated against an objective, laboratory-based reference method, not through adjudication by human readers/experts for image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic imaging device where MRMC studies are common. Its effectiveness is measured by its accuracy in glucose concentration measurement, not by how it assists human readers in interpreting results.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The "Assessment of Performance" section describes the evaluation of the "GLUCOMETER® DEX® Test Sensor (modified)" itself. The device is intended for self-monitoring and professional use, meaning its output (a glucose reading) is directly used. The studies would have focused on the accuracy of these readings, which is the standalone performance of the device.
7. The Type of Ground Truth Used
The document states: "Blood glucose results are referenced to plasma glucose." This indicates that the ground truth was established using a laboratory-based reference method for plasma glucose.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This product (from 2001) is a blood glucose sensor based on a chemical/electrochemical method (amperometric glucose oxidase), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's technology.
§ 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.