# K072732: Ortho T. Cruzi Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Apr 15, 2009 after 567 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
Longest line of descent: 1 generation back to K930272 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930272: Hemagen Chagas' Kit (Eia Method), Hemagen Diagnostics, Inc. (1995) Summary page 4.
- K023889: Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254, Wiener Laboratories Saic (2004) Summary page 1.

## Indications for use
ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of antibodies (Immunoglobulin G) to Trypanosoma cruzi (T. cruzi) in human adult serum (glass, plastic, or serum separator tubes) and plasma (EDTA, lithium heparin or citrate) using whole-cell lysate antigens. Reactive assay results are presumptive evidence of past infection, and in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with Chagas' disease. Definitive diagnosis of an acute phase of infection (including acute congenital infection) must be made by alternate methods, e.g., hemoculture, blood smear. This test is not intended for use on samples of cord blood or screening blood or plasma donors.

Source page: https://510kreport.com/device/K072732
Methodology: https://510kreport.com/methodology