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Pronto Dry is intended for use for the detection of urease enzyme in gastric musocal biopsy specimens for the presumptive determination of Helicobacter pylori symptomatic adult patients. Note: for in vitro diagnostic use only.

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This document is a 510(k) clearance letter from the FDA for a device called "Pronto Dry™". It does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a modern AI/software as a medical device (SaMD) submission would.

This letter is dated June 22, 1999, and relates to a device for detecting Helicobacter pylori. The approval is based on "substantial equivalence" to legally marketed predicate devices, which was a common regulatory pathway at that time, especially for Class I devices like this one (Product Code: LYR). This type of clearance typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics but with data demonstrating the device is as safe and effective as the predicate and does not raise different safety or effectiveness questions.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results against specific acceptance criteria for a new, complex algorithm or AI system.

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