(174 days)
The SASTM Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.
membrane-based immunogold assay
The provided text does not contain detailed information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, or specific study designs (like MRMC or standalone performance). The document is a 510(k) clearance letter from the FDA for a device called "SAS™ Adeno Test," confirming its substantial equivalence to a predicate device.
The letter indicates the device's "Indications For Use" as a rapid visual test for the qualitative detection of adenovirus serotypes in various sample types. However, it does not provide the specific performance data or the study details to prove it meets acceptance criteria. The clearance is based on substantial equivalence, implying that its performance is considered comparable to already legally marketed devices.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth, or study designs based solely on the provided text. The document is primarily a regulatory clearance notification, not a detailed scientific study report.
§ 866.3020 Adenovirus serological reagents.
(a)
Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).(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 the limitations in § 866.9.