(30 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.
Liquid Alkaline Phosphatase Reagent Set
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Liquid Alkaline Phosphatase Reagent Set." It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain information about acceptance criteria, device performance studies, or details relevant to a typical AI/medical imaging device submission.
The letter is for an in vitro diagnostic (IVD) reagent set, not an AI or imaging device. Therefore, the questions posed (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a medical device that utilizes AI, imaging, or has a performance study section.
Based on the provided document, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details.
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.