(51 days)
The TAIDOC CHECK Blood 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.
The TAIDOC CHECK glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The provided text describes the TAIDOC CHECK Glucose Test System, but it does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria.
Instead, it presents:
- General statements about performance: "The studies demonstrated that the TAIDOC CHECK glucose test system is suitable for its intended use." and "The TAIDOC CHECK glucose test system demonstrates satisfactory performance and is suitable for their intended use."
- Comparison to a predicate device: Stating it has "equivalent technological characteristics" and "the same intended use" as the GLUCOMETER ELITE Diabetes Care System (K020208).
- Regulatory approval: The 510(k) clearance letter from the FDA.
Therefore, I cannot populate the table or provide specific details for points 2 through 9 as requested, because that information is not present in the provided document.
To properly answer your request, detailed performance study reports, often found in separate sections of the 510(k) submission or in associated regulatory documents, would be required. This document primarily serves as a summary and the FDA's clearance letter.
§ 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.