(129 days)
The IN TOUCH Diabetes Management Software System is intended for use in home and clinical settings to aid people with diabetes and health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan Brand blood glucose monitoring systems with data management capabilities.
The IN TOUCH Diabetes Management Software System is an optional data management software accessory for use with LifeScan Brand blood glucose monitors such as the ONE TOUCH®, SureStep® and FastTake® Meters. When used with one of these meters, IN TOUCH permits the transfer of data from the glucose meter memory into a computer for enhanced data management capability.
The provided text is a 510(k) submission for the IN TOUCH® Diabetes Management Software System. This submission focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating the device meets specific performance-based acceptance criteria through an analytical or clinical validation study.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
The document primarily describes:
- Device Description: An optional data management software accessory for LifeScan blood glucose monitors.
- Intended Use: To aid in the review, analysis, and evaluation of historical blood glucose test results for diabetes management.
- Substantial Equivalence: Claimed against the LifeScan ONE TOUCH® Profile® Diabetes Tracking System and the MediSense® Precision Link™ Blood Glucose Data Management System.
- Regulatory Classification: Unclassified accessory to a blood glucose test system (75CGA) and an exemption for a "calculator/data processing module for clinical use" (862.2100) is discussed, though deemed not entirely applicable due to home use.
In summary, this document does not contain the information requested about acceptance criteria and a study proving the device meets them because it's a 510(k) submission focused on substantial equivalence rather than a detailed performance validation study.
§ 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.