(146 days)
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro Diagnostic Use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Blood Glucose Meter:
The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro Diagnostic Use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Blood Glucose Test Strips:
Assure Pro Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Control Solution:
For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure Pro Blood Glucose Test Strips.
The provided 510(k) summary for the Assure Pro Blood Glucose Monitoring System is a premarket notification for a modification to an existing device, not a new device. Therefore, the study details are primarily focused on demonstrating that the modifications did not negatively impact the performance, rather than establishing initial performance criteria from scratch.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the overarching acceptance criterion is "appropriate performance" and "substantially equivalent to that of the unmodified version."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance (general) | "Appropriate performance" |
| Precision | Confirmed |
| Hematocrit Range | Confirmed |
| Interferences | Confirmed |
| Minimum Sample Volume | Successful testing confirmed reduced minimum sample volume claim |
| Overall Equivalence | "Substantially equivalent to that of the unmodified version" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample size used for the test set. It broadly states, "Test strips were tested with fresh capillary whole blood."
- Data Provenance: Fresh capillary whole blood was used, implying prospective data collection during the testing phase. The country of origin is not specified but is presumably the USA, where the company and FDA are located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. For blood glucose monitoring systems, the "ground truth" is typically established by comparative measurements against a laboratory reference method, not by human experts interpreting results.
4. Adjudication Method for the Test Set
Not applicable in the typical sense for a blood glucose meter. Ground truth is established through quantitative comparison to a reference method, not through consensus of human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases, and AI assistance is evaluated for its impact on their performance. A blood glucose meter provides a direct quantitative measurement, not an interpretation task for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the testing performed on the device (meter and test strips) is standalone performance. The device itself generates the blood glucose reading without human interpretation of the result. The clinical and non-clinical testing assesses the accuracy and reliability of these direct measurements.
7. The Type of Ground Truth Used
The document implies that the ground truth for performance verification would be established by comparison to a recognized laboratory reference method for blood glucose measurement. While not explicitly stated, this is standard practice for blood glucose meter validation.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the AI sense. This device is a traditional electrochemical blood glucose meter, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI/ML training set was involved.
§ 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.