(35 days)
The Light Diagnostics Pneumocystis carinii DFA intended use is an in vitro procedure for the detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens including sputum, bronchoaveolar lavage, and lung biopsy.
Not Found
I am unable to extract the requested information from the provided document. The document is a 510(k) clearance letter from the FDA for a device called "Light Diagnostics Pneumocystis carinii DFA." This letter primarily addresses regulatory approval and does not contain details about specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.
To get the information you need, you would typically look for a separate clinical study report, a submission summary, or the relevant sections within the 510(k) submission itself, which are not included in these pages.
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).