(93 days)
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.
This document is a letter from the FDA regarding the 510(k) premarket notification for the AIA NexIA Automated Enzyme Immunoassay System. It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, the letter does not contain any information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the provided text. The document focuses solely on the regulatory approval from the FDA, and not on the technical performance studies of the device.
§ 862.2560 Fluorometer for clinical use.
(a)
Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.