(177 days)
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.
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The provided document is an FDA 510(k) clearance letter for the "CL Detect™ Rapid Test" and its Indications for Use statement. It declares the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only states the intended use of the device:
Device Name: CL Detect™ Rapid Test
Indications for Use: The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four-month-old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL Detect™ Rapid Test is to aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.
§ 866.3870
Trypanosoma spp. serological reagents.(a)
Identification. Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toTrypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genusTrypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.(b)
Classification. Class I (general controls).