(157 days)
The Accu-Chek HQ system is a bedside unit that can help health care professionals provide quality patient care by measurement of glucose on an Accu-Chek monitor, and by automating the record keeping associated with blood glucose and quality control tests.
The Accu-Chek HO system is a bedside data management unit that helps provide quality patient care by automating the record keeping associated with blood glucose and quality control tests. The Accu-Chek HQ system collects, stores, transfers information, and generates reports about the monitor, test strips, control solutions, patient results and operator performance for quality assurance.
This device is not intended to provide any diagnosis on patient results. The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system.
The provided text describes a 510(k) summary for the Accu-Chek HQ System, a data management unit for blood glucose and quality control tests. However, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria.
Instead, the document focuses on:
- Device Description: What the Accu-Chek HQ System is and what it does (collects, stores, transfers information, generates reports).
- Intended Use: How the device is meant to be used (automating record-keeping associated with blood glucose and quality control tests, in conjunction with an Accu-Chek monitor).
- Comparison to a Predicate Device: A table comparing the Accu-Chek HQ System to the AccuData Glucose Test Station, highlighting similarities and differences in functionality and intended use.
- Regulatory Information: The FDA's review and determination of substantial equivalence (K983047).
Crucially, the document explicitly states: "This device is not intended to provide any diagnosis on patient results." and "The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system." This indicates that the device's primary function is data management and record-keeping, and its performance is not evaluated in terms of diagnostic accuracy or clinical outcomes.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because this information is not present in the provided text. The document describes a "data processing module for clinical use" where the "performance" is more about data accuracy and transfer, rather than a clinical diagnostic performance that would typically have specific sensitivity/specificity, accuracy, etc. acceptance criteria and a corresponding study.
§ 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.