(12 days)
Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue® Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
HemoCue® Glucose 201 System
I am sorry, but the provided text from the FDA 510(k) summary for the HemoCue® Glucose 201 System does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and study proving device performance.
Specifically, this document is a letter from the FDA acknowledging the substantial equivalence of the device and its indications for use. It's a regulatory approval document, not the scientific study report itself.
Here's what I can and cannot provide based on the given text:
Information I CANNOT provide from this document:
- A table of acceptance criteria and the reported device performance: This detailed data is not present.
- 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 their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and this type of study is typically for imaging devices, not glucose meters.
- If a standalone study was done: While the FDA review implies performance data was submitted, the details of such a study (standalone or otherwise) are not in this letter.
- The type of ground truth used: Not specified in this document. For a glucose meter, this would typically involve 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.
Information I CAN provide based on the given text:
- Device Name: HemoCue® Glucose 201 System
- Regulation Number/Name: 21 CFR 862.1345, Glucose test system
- Regulatory Class: Class II
To answer your request completely, I would need access to the actual HemoCue® Glucose 201 System's 510(k) submission summary or the underlying study reports, which are not provided in the text.
§ 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.