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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.

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