(201 days)
The Kalazar Detect™ Test is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.
Not Found
This document is an FDA 510(k) clearance letter for the "Kalazar Detect™ Rapid Test for the Detection of Visceral Leishmaniasis." As such, it primarily focuses on the regulatory approval and substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive study proving the device meets specific acceptance criteria in the manner one might find for a more complex diagnostic or AI-based device.
Therefore, many of the requested fields cannot be directly extracted from this document because the letter does not include the detailed study design and results for performance evaluation.
However, I can provide the information that is present or can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) or a direct performance table for the Kalazar Detect™ Rapid Test. The clearance is based on substantial equivalence to legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the FDA clearance letter. It would typically be found in the manufacturer's 510(k) submission, which is not included here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the FDA clearance letter. Ground truth for diagnostic tests typically relies on established clinical diagnoses or reference methods, but the specifics of how this was established for the performance evaluation are not detailed here.
4. Adjudication Method for the Test Set:
This information is not provided in the FDA clearance letter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This is a rapid immunoassay kit. An MRMC study is generally relevant for imaging or interpretation-heavy diagnostics where human reader performance is a key variable. Given the nature of a rapid immunochromatographic strip assay, an MRMC study is highly unlikely to have been performed or relevant in the context of improving human reader performance with AI assistance. The device itself is not an AI algorithm.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
The Kalazar Detect™ Test is a rapid immunoassay kit, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. The device is designed for professional in vitro diagnostic use, meaning a human interprets the visual result on the strip.
7. The Type of Ground Truth Used:
While not explicitly stated in the letter, for an in vitro diagnostic test for Leishmaniasis antibodies, the ground truth would typically be established by a combination of clinical diagnosis (e.g., symptoms, geographic exposure) and confirmation by a validated reference method, such as microscopy, PCR, or culture for L. donovani in patient samples.
8. The Sample Size for the Training Set:
This information is not provided in the FDA clearance letter. For an immunoassay, the concept of a "training set" as understood in machine learning is not directly applicable. Instead, the device development would involve various stages of prototype testing and optimization using relevant biological samples.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the FDA clearance letter. Similar to the test set, the "ground truth" for samples used during development would be established through robust reference methods for diagnosing Visceral Leishmaniasis.
§ 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).