(55 days)
The MediSense Precision PCx Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The MediSense Precision PCx Point of Care Management System is for home (lay user) or professional use. The PCx Point of Care Management System for Blood Glucose Testing is for monitoring blood glucose concentration in patients with diabetes mellitus or other conditions.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood, provided that the sample is used within 30 minutes.
The Precision PCx Point of Care Management System for Blood Glucose Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample providing a quantitative measure of glucose in whole blood and control solutions.
This document is a 510(k) Premarket Notification summary for the MediSense Precision PCx Point of Care Management System for Blood Glucose Testing. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information or acceptance criteria requested for a medical device's performance evaluation.
Specifically, the following requested information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This information is typically found in the performance data section of a 510(k) submission, which is not included here.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. Blood glucose meters typically do not involve human readers interpreting images, so an MRMC study would generally not be applicable.
- Standalone performance (algorithm only without human-in-the-loop performance): While the device is an automated system, specific standalone performance study results, including metrics and methods, are not provided.
- The type of ground truth used: Not explicitly stated, though for blood glucose meters, the ground truth is typically a laboratory reference method.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document primarily focuses on the regulatory aspects of the device, such as its classification, predicate devices, and intended use, rather than the detailed technical performance data from clinical or analytical studies.
§ 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.