(121 days)
The Tyson Bio HT100-A Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The Tyson Bio HT100-A Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-A Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.
The Tyson Bio HT100-C Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The Tyson Bio HT100-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.
The Tyson Bio HT100-A Blood Glucose Monitoring System (with Voice feature) consists of three main components: the meter (with built-in Voice feature), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as K170079) and Tyson Bio 50H Control Solution (Control Solutions are the same as K170079) can be used with the Tyson Bio HT100-A Blood Glucose Monitoring System.
The Tyson Bio HT100-C Blood Glucose Monitoring System (with Voice and Bluetooth features) consists of three main components: the meter (with built-in Voice and Bluetooth features), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as K170079) and Tyson Bio 50H Control Solutions (Control Solutions are the same as K170079) can be used with the Tyson Bio HT100-C Blood Glucose Monitoring System.
The Tyson Bio HT100-A / HT100-C Blood Glucose Monitoring System consists of:
- a. Tyson Bio HT100-A / HT100-C Blood Glucose Meter
- Tyson Bio 50H Test Strips b. (Test Strips are the same as K170079)
The provided text describes the Tyson Bio HT100-A and HT100-C Blood Glucose Monitoring Systems, which are medical devices intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The document is a 510(k) summary submitted to the FDA for premarket notification.
However, the document does not contain information related to acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how training ground truth was established.
The document primarily focuses on:
- Intended Use: For self-testing by people with diabetes at home to monitor diabetes control. Not for diagnosis, screening, or neonatal use.
- Device Description: Consists of a meter (HT100-A with voice, HT100-C with voice and Bluetooth) and test strips.
- Test Principle: Electrochemical biosensor technology using glucose dehydrogenase.
- Predicate Device Comparison: Lists similarities and differences with the predicate device (Tyson Bio HT100, K170079). Similarities include intended use, enzyme, test principle, measuring range, hematocrit range, sample volume, AST, coding, operating temperature/humidity, memory, battery, alarm, buttons, and meter size. Differences are mainly the addition of voice features, slight changes in meter weight, and functional back cover design.
- Conclusion: Claims substantial equivalence to the predicate device.
Since the provided text does not contain the requested information regarding acceptance criteria and study details, it is impossible to populate the table or answer the specific questions about the study design, ground truth, and sample sizes. The document is a regulatory submission for premarket notification, which often summarizes information but does not include the detailed raw data or study methodologies that would be found in a full study report.
§ 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.