(30 days)
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
The FreeStyle InsuLinx Meter, in conjunction with the FreeStyle InsuLinx Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.
The device automatically logs blood glucose results to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Users can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
The FreeStyle InsuLinx System has 'plug and play' software that automatically installs on a computer without the need for a CD or internet access (via the meter's USB port and a provided cable). It also provides access to the structured reports for both the healthcare professionals and patients.
The provided document is a 510(k) premarket notification for the FreeStyle InsuLinx Blood Glucose Monitoring System, detailing its substantial equivalence to a predicate device. This submission primarily focuses on a modification to include a different lancing device and a change in the recommended cleaning and disinfection wipes. While it outlines the acceptance criteria for accuracy and precision, it does not include a detailed study proving the device meets these criteria in the traditional sense of a clinical trial report with specific patient data, expert ground truth establishment, or statistical analyses like MRMC studies.
Instead, the document asserts substantial equivalence based on the device's fundamental technology, indications for use, and performance characteristics (accuracy and precision) being identical to the predicate device (K120568). The only differences noted are related to the lancing device and the disinfectant wipes.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (as per predicate device) | Reported Device Performance (as per predicate device, asserted to be same for modified device) |
|---|---|---|
| Precision | At glucose levels below 75 mg/dL, average SD is ≤ 5 mg/dL. At glucose levels ≥ 75 mg/dL, average CV is ≤ 5%. | Same |
| Accuracy | 95% of results should fall within ± 15 mg/dL of the comparative method results at glucose concentrations |
§ 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.