(16 days)
The REVOLUTION TD-4229 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the REVOLUTION TD-4229 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
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The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the Revolution TD-4229 Blood Glucose Monitoring System, detailing that the device is substantially equivalent to a legally marketed predicate device.
Specifically, the document includes:
- Trade/Device Name: Revolution TD-4229 Blood Glucose Monitoring System
- Regulation Number: 21 CFR §862.1345
- Regulation Name: Glucose test system
- Regulatory Class: Class II
- Product Code: NBW, CGA
- Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh). Intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control. Not for diagnosis or screening of diabetes mellitus, and not for use on neonates. Alternative site testing is only for steady-state blood glucose conditions.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Results from standalone algorithm performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.