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The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.

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This looks like a 510(k) clearance letter from the FDA for a diagnostic device. Unfortunately, clearance letters typically do not contain the detailed study results, acceptance criteria, or performance data that you are requesting. They primarily state that the device has been found substantially equivalent to a legally marketed predicate device.

To get the information you're asking for, one would typically need to refer to the 510(k) summary or the full 510(k) submission document itself, which is often much more detailed. These documents would contain the clinical study design, acceptance criteria, and performance outcomes.

Based solely on the provided text, I cannot provide the requested information. The document only confirms the device's clearance and its intended use.

If you had the 510(k) summary or the full submission document, I would be looking for sections that detail:

• Clinical Performance Studies: This is where the bulk of the requested information would be found.
• Performance Characteristics: Typically a summary of sensitivity, specificity, accuracy, etc.
• Study Design: Details on population, sample size, ground truth, etc.
• Acceptance Criteria: Predetermined thresholds for performance metrics.

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