# K161947: Chagas Detect Plus Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: InBios International, Inc.
- Decided: Dec 16, 2016 after 155 days
- Product code: MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi)
- Device class: 1
- Regulation: 21 CFR 866.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K161947
Methodology: https://510kreport.com/methodology