(159 days)
The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in endocervical and male urethral swab specimens, and in female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.
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The provided text is a 510(k) premarket notification approval letter for the "APTIMA™ Combo 2 Assay" and the "TIGRIS® DTS™ Automated Analyzer." It primarily focuses on the regulatory approval and indications for use.
Crucially, this document does not contain the detailed study information, acceptance criteria tables, or performance metrics requested in your prompt. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance, but it does not present the specific data from the studies that would have been submitted to FDA to prove that substantial equivalence. These details would typically be found in the actual 510(k) submission document itself, not in the FDA's approval letter.
Therefore, I cannot provide the requested information based on the text provided.
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).