(201 days)
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Not Found
No
The summary describes a rapid immuno-chromatographic strip assay, which is a traditional diagnostic technology and does not mention any AI or ML components.
No
The device is described as an "in vitro diagnostic use only" test for detecting antibodies. It is used for diagnosis, not for treating or preventing a disease, which is the function of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "This test is intended for laboratory or professional in vitro diagnostic use only."
No
The device is described as a rapid immuno-chromatographic strip assay, which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This test is intended for laboratory or professional in vitro diagnostic use only." This statement directly identifies the device as an IVD.
N/A
Intended Use / Indications 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.
Product codes
LOO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory or professional in vitro diagnostic use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
2
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 |
|---|---|---|
| ------------------ | --------------- | ------------------ |
Freddie Poole.
(Division Sign-Off) Division of Clinical Laboratory Devices