(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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged around the upper portion of the circle.
MAY 0 6 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Estela I. Raychaudhuri President/CEO InBios International, Inc. 562 1st Ave. S. Suite 600 Seattle, WA 98104
Re: K023483
Trade/Device Name: Kalazar Detect™ Rapid Test for the Detection of Visceral Leishmaniasis Regulation Number: 21 CFR 866.3870 Regulation Name: Trypanosoma Spp. Serological Reagents Regulatory Class: Class I Product Code: LOO Dated: April 1, 2003 Received: April 2, 2003
Dear Ms. Raychaudhuri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (if Known): KNOWN): KOSZ 483
device name: Kalazar detect™ Rapid TEST For The detection OF VISCERAL LEISHMANIASIS
INDICATION FOR USE:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | or | Over-the-Counter |
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Freddie Poole.
(Division Sign-Off) Division of Clinical Laboratory Devices < 0 . 510(k) Number -
§ 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).