(88 days)
The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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 above systems can be used only during steady-state blood glucose conditions.
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I am sorry, but the provided text from the FDA 510(k) summary for the TaiDoc Technology Corporation Blood Glucose Monitoring Systems (K090185) does not contain the detailed information necessary to answer your request about acceptance criteria and the specifics of a study proving device performance.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It lists the trade names and regulation numbers, and outlines the general controls and requirements for the device. It also includes an "Indications for Use" statement, defining how the device is intended to be used.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for the test set or data provenance.
- Details about experts used for ground truth (number, qualifications, adjudication).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
To obtain this information, you would typically need to refer to the full 510(k) submission, which is often much more detailed and includes the actual performance data and study methodologies. The document provided is only the FDA's clearance letter.
§ 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.