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K Number
K161947
Device Name
Chagas Detect Plus Rapid Test
Manufacturer
INBIOS INTERNATIONAL, INC.
Date Cleared
2016-12-16

(155 days)

Product Code
MIU
Regulation Number
866.3870
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi. The CDP when used in conjunction with other serological and clinical information is useful for the diagnosis of individuals with Chagas disease. Definitive diagnosis of an acute phase infection (including acute congenital infection) must be made by alternative methods, e.g., hemoculture, blood smear. This test is not intended for use on cord blood or for screening blood or plasma donors.

Device Description

The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood).

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the Chagas Detect™ Plus Rapid Test. It confirms the device's substantial equivalence to legally marketed predicate devices.

However, the document does not contain any information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. It is for a rapid immunochromatographic strip assay, which is a laboratory diagnostic test, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML model's performance evaluation cannot be extracted from this document.

The document discusses:

  • The device name: Chagas Detect™ Plus Rapid Test
  • Its intended use: Qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood.
  • Regulatory information: Regulation Number, Name, Class, and Product Code.
  • The FDA's determination of substantial equivalence.
  • General controls provisions and other regulatory requirements for the device.

To fulfill the request, a document describing an AI/ML medical device's performance study would be necessary.

§ 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).