(473 days)
The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.
The TRUE METRIX GO Self Monitoring Blood Glucose 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 TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing.
The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
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This document is an FDA 510(k) clearance letter for the TRUE METRIX GO Self Monitoring Blood Glucose System. While it states the indications for use, it does not contain detailed acceptance criteria, study data, or information regarding ground truth establishment, expert qualifications, or sample sizes for training and testing as requested. This type of information is typically found in the submission itself, not the clearance letter.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission document (K143548) or an equivalent performance study report for the device.
The provided text only includes:
- Device Name: TRUE METRIX GO Self Monitoring Blood Glucose System
- Regulation Number/Name: 21 CFR 862.1345, Glucose test system
- Regulatory Class: II
- Product Code: NBW, LFR
- Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood from the fingertip, for self-testing by people with diabetes at home to monitor diabetes control. Not for diagnosis, screening, neonatal use, or alternative site testing.
- Type of Use: Over-The-Counter Use (21 CFR 801 Subpart C)
§ 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.