(496 days)
The CareSens N Feliz 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 N Feliz 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 N Feliz BT Blood Glucose Monitoring System is comprised of the CareSens N Blood Glucose Test Strips and the CareSens N Feliz BT Blood Glucose Meter.
This FDA 510(k) clearance letter for the CareSens N Feliz BT Blood Glucose Monitoring System does not contain the detailed information required to answer all the questions about specific acceptance criteria and the study that proves the device meets those criteria.
The letter primarily confirms that the device is substantially equivalent to a predicate device and outlines regulatory obligations. It does not include performance data, study design details, or specific acceptance criteria for analytical or clinical performance characteristics of the glucose monitoring system.
Therefore, I cannot provide a complete answer with the requested information based only on the provided text.
However, based on common practices for glucose monitoring systems, I can infer some general aspects and state what information is missing.
Here's an assessment based on the available text and what would typically be found in a 510(k) submission for such a device:
1. A table of acceptance criteria and the reported device performance
Information Not Provided in the Text. The FDA 510(k) letter does not include a table of acceptance criteria or performance data. For a blood glucose monitoring system, this table would typically refer to the ISO 15197 standard (or equivalent FDA guidance) for accuracy of blood glucose measurements.
Typical Acceptance Criteria (Inferred, not from provided text):
| Criterion | Typical Acceptance Limit (Example, per ISO 15197:2013) | Reported Device Performance (Missing) |
|---|---|---|
| Accuracy (Difference from Reference Method) | (For glucose concentration |
§ 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.