(21 days)
The Prestige LX Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
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This document is a 510(k) clearance letter for the Prestige LX Blood Glucose Test System from the FDA, dated September 24, 1999. It states that the device is substantially equivalent to legally marketed predicate devices. Unfortunately, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Device Performance: The letter confirms substantial equivalence but does not list specific performance metrics (e.g., accuracy, precision) or their corresponding acceptance criteria for the Prestige LX system.
- Study Details: There is no mention of the study design, sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any testing performed. This type of information would typically be found in the 510(k) submission itself, not the FDA's clearance letter.
- MRMC, Standalone, Training Set: These are specific types of studies or data points related to performance evaluation, none of which are discussed in this document.
In summary, based only on the provided FDA clearance letter (K992988) for the Prestige LX Blood Glucose Test System:
I cannot provide the requested information about acceptance criteria and the detailed study that proves the device meets those criteria. This document is a regulatory approval notice and does not contain the technical performance data or study methodology. To obtain that information, one would typically need to review the original 510(k) submission documentation, which is not provided here.
§ 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.