(90 days)
The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips.
The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The TD-4183 system kit includes the TD-4183 Blood Glucose meter with blood glucose measuring function and the TD-4183 Blood Glucose test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger as an aid in monitoring the effectiveness of glucose control.
The provided document is a 510(k) summary for the TaiDoc TD-4183 Blood Glucose Monitoring System. It describes the device, its intended use, and a comparison to a predicate device (TD-4277 Blood Glucose Monitoring System). It also briefly mentions non-clinical and clinical studies conducted to support the substantial equivalence claim.
However, the document does not contain the detailed acceptance criteria and the results of a study that proves the device meets those criteria in the format requested. Specifically:
- No detailed table of acceptance criteria and reported device performance is provided. It only states that "all performance criteria were met."
- No specific sample sizes for the test set or training set are given for any of the studies (non-clinical or clinical).
- No information on data provenance (country of origin, retrospective/prospective) is provided.
- No details are available regarding expert involvement (number of experts, qualifications) for ground truth establishment or adjudication methods.
- No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned, as this is a blood glucose monitoring system, not an imaging AI device where such studies are common.
- No mention of a standalone algorithm-only performance study for the same reason.
- No specific type of ground truth used is detailed, though for a blood glucose monitor, it would typically involve laboratory reference methods.
- No information on how ground truth for the training set was established (as sensor calibration and performance is generally based on known glucose concentrations from laboratory standards).
The document is primarily a regulatory submission summary, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical report of the studies performed.
Therefore, based on the provided text, I cannot complete the requested information in the specified format. The available information is too high-level for the detailed breakdown required by the prompt regarding acceptance criteria and study particulars.
§ 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.