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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.

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