(151 days)
The CareSens S Fit Blood Glucose Monitoring System is intended for the surement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Fit 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 Blood Glucose Test Strips are with the CareSens S Fit Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The CareSens S Fit BGMS is a derivation from the same design file as it predicate device, CareSens N Premier and CareSens N Premier BT Blood Glucose Monitoring System, utilizing a new test strip. This Premarket Notification (510(k) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device.
The CareSens S Fit BGMS consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Level 1" and "Level 2" ranges). The CareSens S Fit BGMS is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The following items are included in the CareSens S Fit BGMS Blood Glucose Monitoring system:
- 1 CareSens S Fit Blood Glucose Meter
- 10 CareSens S Blood Glucose Test Strips
- 1 Lancing device
- 10 Lancets
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 1 Battery (3.0V lithium battery)
The following items are compatible with the CareSens S Fit BGMS and are available separately.
- CareSens S Blood Glucose Test Strips
- CareSens S Glucose Control Solution
The provided text describes the performance testing and acceptance criteria for the CareSens S Fit Blood Glucose Monitoring System, particularly in the context of its 510(k) submission (K180866) to the FDA.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document frequently refers to "acceptance criteria" and "satisfying" or "meeting" them, particularly referencing the FDA SMBG Guidance (2016). While specific numerical acceptance criteria for each test (e.g., CV% for precision above a certain threshold) are often implied rather than explicitly stated in a single table, the key accuracy criteria from the Method Comparison/User Performance study are provided.
| Performance Metric | Acceptance Criteria (Implied/Referenced) | Reported Device Performance (CareSens S Fit BGMS) |
|---|---|---|
| Accuracy (Method Comparison/User Performance) | FDA SMBG Guidance (2016) criteria for accuracy: |
- For glucose concentrations 250 mg/dL and
§ 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.