(25 days)
The CareSens S Fit BT Blood Glucose Monitoring System consists of the CareSens S Fit BT Blood Glucose Meter and the CareSens S Blood Glucose Test Strips. The CareSens S Fit BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Fit BT Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens S Fit BT Blood Glucose Monitoring System consists of the CareSens S Fit BT Blood Glucose Meter and the CareSens S Blood Glucose Test Strips.
This FDA 510(k) clearance letter does not contain the specific acceptance criteria, study details, and performance data requested. It primarily grants market clearance for the CareSens S Fit BT Blood Glucose Monitoring System based on substantial equivalence to predicate devices.
To answer your questions, I would need access to the actual 510(k) submission summary or a separate performance study report for the device. The provided document only includes:
- Trade/Device Name: CareSens S Fit BT Blood Glucose Monitoring System
- Regulation Number: 21 CFR 862.1345
- Regulation Name: Glucose test system
- Regulatory Class: Class II
- Product Code: NBW
- Indications for Use: The system is intended for quantitative measurement of glucose in fresh capillary whole blood samples from fingertips, for self-testing by people with diabetes at home to monitor diabetes control. It is for single-person use, not for neonates, and not for diagnosis or screening of diabetes.
- Type of Use: Over-The-Counter Use
Without the actual study data, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.
§ 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.