(71 days)
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.
Not Found
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.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).