(21 days)
These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use. These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
Not Found
The provided text is a 510(k) summary for a blood glucose and blood pressure measurement system. It does not contain a detailed study report with acceptance criteria and device performance as requested. The document primarily focuses on the FDA's regulatory decision regarding substantial equivalence to a predicate device.
Therefore, I cannot extract the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document.
The document does state the "Indications for Use" for the device:
- Blood Glucose Measurement: For in vitro diagnostic use, quantitative measurement of glucose in capillary whole blood from the fingertip. Intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Not intended for diagnosis or screening for diabetes mellitus, and not for use on neonates.
- Blood Pressure Measurement: To measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual (over age 16) at home using an inflatable cuff around the wrist. Cuff circumference is limited to 5.25"~7.75".
§ 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.