(214 days)
Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric I your id is intended for the presumptive determination of Helicobacter pylori in symptomatic patients. ARJ Medical's Pylo-Plus Rapid Urease Tests are for single use by medical and ANJ Medical 3 1 710 1 148 Rapia Created for use in screening at-risk patients to assist diagnosis in the field of Gastroenterology.
Pylo-Plus is a Rapid Urease Test.
The provided document is a 510(k) clearance letter from the FDA for the "Pylo-Plus" device and its Statement of Indications for Use. It does not contain the detailed information about acceptance criteria, study design, or performance metrics typically found in a clinical study report or a 510(k) summary.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or MRMC study results directly from these documents.
This type of information would typically be found in the 510(k) Summary (Section 510(k) Summary or 510(k) Statement) submitted by the manufacturer to the FDA, which often includes a summary of the clinical or analytical performance studies. The provided documents are the FDA's clearance letter and the "Indications for Use" statement, which confirm the device's clearance and intended use but not the underlying study data.
§ 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).