(112 days)
The Card Guard SelfCheck Gluco glucose test system is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Not Found
The provided text is an FDA 510(k) clearance letter for the SelfCheck™ Gluco glucose test system. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
Specifically, the document makes no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details about the study design.
- The number or qualifications of experts used for establishing ground truth.
- Any adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, or any effect sizes of human readers with/without AI assistance. (This is irrelevant for a glucometer as it's not an AI-assisted diagnostic imaging device).
- Whether a standalone (algorithm only) performance study was done. (Again, irrelevant for this type of device).
- The type of ground truth used (e.g., pathology, outcomes data). (For a glucometer, ground truth typically comes from lab reference methods).
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot provide the requested information from this document. The letter focuses on regulatory approval based on substantial equivalence, not on the detailed technical data of the performance study itself.
§ 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.