(449 days)
SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions.
The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing newborns.
SD CHECK GOLD blood glucose system is applicable to monitor blood glucose in capillary whole blood.
SD CHECK GOLD blood glucose monitoring system is comprised of the following.
- SD CHECK GOLD blood glucose meter
- SD CHECK GOLD blood glucose test strip i
- SD CHECK GOLD control solution -
- i SD CHECK GOLD check strip
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
I am sorry, but the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance. The document is a 510(k) summary for the SD CHECK GOLD blood glucose monitoring system, declaring its substantial equivalence to predicate devices, but it does not include the results of clinical performance studies with specific statistical metrics, sample sizes, or details about ground truth establishment.
Therefore, I cannot generate the table of acceptance criteria and reported device performance or answer questions 2 through 9 based on the given input.
§ 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.