(73 days)
Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, Rotavirus.
The subject device provides A549 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided text is a 510(k) Summary for a cell culture product (FreshCells™ A549 cells) intended for virus isolation and identification. It does not describe an AI/ML-powered device and therefore does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets them.
Specifically, the document focuses on the characteristics of the cell line itself and its intended use for viral isolation, comparing it to a predicate device. It details non-clinical tests to characterize the product's appearance, growth, sterility, isoenzyme analysis, and virus susceptibility. These are not performance metrics for an AI/ML algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(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 § 864.9.