(204 days)
DiaTrue Plus Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample from the fingertip and the palm. The alternate site testing can be only used during steady-state blood glucose monitoring. The DiaTrue Plus Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.
The DiaTrue Plus Blood Glucose Test Strips are used with the DiaTrue Plus Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip and the palm.
The DiaTrue Glucose Control Solutions are for use with the DiaTrue Plus Blood Glucose Test Strips and the DiaTrue Plus Glucose meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.
The DiaLife Mini Blood Glucose Management Software is designed for use in the home with the DiaTrue Plus Blood Glucose Monitoring System to allow users to transmit data from meter to their computer. It is an optional data management software accessory for use with the DiaTrue Plus Blood Glucose Monitoring System.
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The provided text is a 510(k) premarket notification letter for the DiaTrue Plus Blood Glucose Monitoring System. It describes the device, its intended use, and the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to answer all parts of your request.
Specifically, the document refers to the submission as "premarket notification of intent to market" and states that "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent". This implies that the specific studies and data proving the device meets acceptance criteria are part of the detailed submission document (the 510(k) itself), which is not fully provided here.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance: This detailed information is not present. The document only states the device is "substantially equivalent" to predicate devices, implying that its performance is comparable, but does not provide the specific metrics or acceptance thresholds.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: This type of study is typically for evaluating AI/CAD systems that assist human readers. A blood glucose monitor is a standalone diagnostic device, so an MRMC study is generally not applicable in this context. The document also does not mention any such study.
- Standalone (algorithm only) performance: While the device itself is standalone, the document doesn't provide specific performance metrics (e.g., accuracy, precision) that would be the output of a standalone performance study.
- Type of ground truth used: Not mentioned. For blood glucose meters, the ground truth is usually established by a highly accurate laboratory reference method.
- Sample size for the training set: Not mentioned. (Blood glucose meters are typically calibrated rather than "trained" in the machine learning sense, but the specific validation details are missing).
- How the ground truth for the training set was established: Not mentioned.
What the document does provide:
- Device Name: DiaTrue Plus Blood Glucose Monitoring System
- Indications for Use: Quantitative measurement of glucose level in fresh capillary whole blood from fingertip and palm by a single person at home to monitor diabetes control. Not for diagnosis, screening, or neonates.
- Regulatory Class: II
- Product Code: NBW, CGA, JJX, JQP
- Date of Submission: July 02, 2013
- Outcome: Substantially Equivalent determination by FDA.
To answer your request comprehensively, you would need to examine the full 510(k) submission for K130244, which would contain the detailed study reports and data.
§ 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.