(6 days)
The Non-variola Orthopoxvirus Real-ime PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular rash specimens and viral cell culture lysates submitted to a Centers for Disease Control and Prevention designated laboratory. The assay detects nonvariola Orthopoxvirus DNA, including vaccinia, cowpox, monkeypox and ectromelia viruses at varying concentrations. This assay does not differentiate vaccinia virus or monkeypox virus from other orthopoxviruses detected by this assay and does not detect variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash Illness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness.
Results of this assay are for the identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not prection virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Centers for Disease Control and Prevention designated laboratories.
Unchanged from original submission (K221834).
The provided text is a 510(k) Summary for the "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set". This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and some general performance characteristic categories.
However, the document does not include detailed information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or their data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Specific types of ground truth used (beyond implying laboratory testing).
- Sample size for training sets.
- How ground truth for training sets was established.
Instead, for performance characteristics, the document states: "Inquiries regarding performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention." It mentions that the Limit of Detection (LOD) was determined through an analytical sensitivity study and broadly references analytical sensitivity and specificity, as well as clinical performance, but without providing the detailed results or methodologies for these studies within this summary.
The document highlights the device's intended use for in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA and the need to use results in conjunction with other diagnostic assays and clinical observations. It also specifies use limitations to "Centers for Disease Control and Prevention designated laboratories."
Therefore, based solely on the provided text, I cannot provide the requested detailed information regarding acceptance criteria and study particulars. The document explicitly directs inquiries about these performance characteristics to the CDC.
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