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The OSOM® Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A streptococcal antigen directly from throat swab specimens.

The OSOM® Strep A Test is a color immunochromatographic assay.

This document is a 510(k) clearance letter from the FDA for the OSOM® Ultra Strep A Test. It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, details of a study proving the device meets acceptance criteria, or any of the specific information requested in your prompt.

The letter is primarily focused on confirming the regulatory clearance for the device and outlining the manufacturer's ongoing responsibilities. It mentions the "indications for use" as an enclosure, but this enclosure (Attachment #1) only describes what the device is for (qualitative detection of Group A streptococcal antigen from throat swab specimens) and not the performance criteria or study results.

Therefore, based solely on the provided document, I cannot answer your questions regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) submission itself or in a summary document within that submission, not in the clearance letter.

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