(247 days)
The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates.
The DIAVUE Blood Glucose Test Strips are to be used with the DIAVUE Prudential Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Meter and DIAVUE Blood Glucose Test Sreips to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
The DIAVUE Prudential Blood Glucose Monitoring System consists of glucose meter, quick start user guide, user manual, warranty card, and carrying bag. Test strips, control solutions or sterile lancets can be purchased separately.
DIAVUE Control Solution contains a known amount of glucose that reacts with test strips made by BioCare. Three levels of control solutions are available : level 1.level 2 and level 3.Operation of the control solution test is similar to blood glucose test except that you use DIAVUE control solution instead of a drop of blood. The control solutions should provide results within an expected range printed on the test strip vial label.
This 510(k) summary does not contain the detailed study information needed to fully answer the request. The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of regulatory clearance, rather than presenting a comprehensive clinical study report with acceptance criteria and performance data in the requested format.
Here's an analysis of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not include a table of acceptance criteria or detailed reported device performance in the typical format requested (e.g., accuracy against a reference method with specific percentages within certain glucose ranges). Instead, it states the device is "substantially equivalent" to a predicate device, which implies its performance is comparable and therefore acceptable.
Missing Information: Specific numerical acceptance criteria for accuracy, precision, or other performance metrics. Details of the device's actual performance against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Substantial equivalence claims often rely on bench testing and comparison to predicate device specifications, which may not involve large human subject studies detailed in this document.
Missing Information: Sample size for the test set, country of origin of data, and whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The 510(k) summary does not mention the use of experts to establish a ground truth for a test set. For glucose monitoring systems, ground truth is typically established by laboratory reference methods rather than expert consensus on interpretive tasks.
Missing Information: Number of experts, their qualifications.
4. Adjudication Method for the Test Set
Since expert consensus for ground truth is not mentioned, an adjudication method is also not applicable or not detailed in this summary.
Missing Information: Adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
MRMC studies are typically for devices where human interpretation of images or other data is central. For a blood glucose monitoring system, the "reader" is the device itself, and the "case" is the blood sample. This type of study is not applicable to a glucose meter in the way it would be for an imaging device. The document does not describe any study involving human readers improving with or without AI assistance.
Missing Information: MRMC study details, effect size.
6. Standalone Performance Study (Algorithm Only)
The DIAVUE Prudential Blood Glucose Monitoring System is an algorithm/device that performs measurement without human intervention in the measurement process itself (human-in-the-loop is for sample application and reading the result, not for interpreting raw data). Therefore, the "device performance" (alone) is what is being reviewed. However, the document does not present the detailed results of such a study, only the claim of substantial equivalence.
Information Present: The device is a standalone algorithm/device for measurement.
Missing Information: The results of a standalone performance study.
7. Type of Ground Truth Used
For a blood glucose monitoring system, the ground truth would typically be established by a laboratory reference method, such as a YSI glucose analyzer, which is considered highly accurate. The 510(k) summary does not explicitly state the type of ground truth used but it is implied to be a highly accurate chemical analysis method.
Missing Information: Explicit statement of the specific reference method used for ground truth.
8. Sample Size for the Training Set
The 510(k) summary does not mention any "training set." Glucose monitoring systems are typically calibrated during manufacturing and validated through performance testing, rather than "trained" in the manner of machine learning algorithms.
Missing Information: Sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is also not available in the document.
Missing Information: Method for establishing ground truth for the training set.
In conclusion: The provided 510(k) summary serves as a regulatory document for demonstrating substantial equivalence. It does not contain the detailed clinical study data, acceptance criteria, or methodological specifics that would be found in a full clinical trial report or a comprehensive validation study. The closest the document comes to "study information" is a list of similarities and differences with a predicate device, which is the basis for its claim of substantial equivalence.
§ 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.