510(k) · Cleared
ClearedChagas Detect Plus Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InBios International, Inc. · MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Cleared on Dec 16, 2016 after a 155-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 16, 2016
- Review
- 155 days
- Class
- Class I
- Product code
- MIU
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MIU devicesMIU Enzyme Linked Immunosorbent Assay, T. Cruzi: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MIU
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MIU
Too few MIU 510(k)s in any year since 2007 to give a median.
Recalls per year · MIU
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIU
3in 2019
MAUDE reports naming product code MIU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 0 | — | 1 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (152 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161947: Chagas Detect Plus Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161947
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026