(43 days)
Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the HEp-2 cell line, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, HSV, Coxsackie B, Measles, Parainfluenza, Poliovirus, RSV.
The subject device provides frozen HEp-2 cells in measured quantities allowing the user to simply thaw and dilute the cells to a prescribed volume, plant prescribed volumes in appropriate containers and after a few days, the cell monolayers will be confluent and ready to use for virus isolation and identification.
The provided text is a 510(k) summary for a medical device (FreshFrozen Cells™) and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in studies for diagnostic devices or AI algorithms. The document describes the device's intended use and characteristics, comparing it to a predicate device. It mentions "non-clinical tests" to characterize the product's appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility, but it does not provide specific acceptance criteria or performance results from these tests.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I answer the questions regarding sample sizes, ground truth, expert involvement, or comparative effectiveness studies. The information simply isn't 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.