510(k) · Cleared
ClearedOrtho T. Cruzi Elisa Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Cleared on Apr 15, 2009 as substantially equivalent to K930272 (Hemagen Diagnostics, Inc., 1995) and 1 other predicate after a 567-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 15, 2009
- Review
- 567 days
- Class
- Class I
- Product code
- MIU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930272 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930272 Hemagen Chagas' Kit (Eia Method)Hemagen Diagnostics, Inc. · 1995
- This deviceK072732 Ortho T. Cruzi Elisa Test SystemOrtho-Clinical Diagnostics, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930272 | Hemagen Chagas' Kit (Eia Method) | Hemagen Diagnostics, Inc. | 1995 | — |
| 0 (this device) | K072732 | Ortho T. Cruzi Elisa Test System | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930272 | Hemagen Chagas' Kit (Eia Method)Summary page 4…ROPRIETARY 'traditional 510(k) Application 7 Comparison to Predicate Device The ORTIlO Z cruzi EL[SA lest System is substantially equivalent to K930272 Ilemagen Chagas' Kit (EIA Method) - lemagen Diagnostics, Inc., and/or K023889 Enzyme Linked Inmunosorbent Assay, 7 cruzi -… | 1995 |
| * | K023889 | Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254Summary page 1…e The ORTHO 77cruzi ELISA Test System is substantially equivalent to K(930272 Hemnagen Chagas' Kit (EIA Method) - Hemagen Diagn~ostics, Inc., and/or K023889 Enzyme Linked Immurosorbent Assay, 77 cnizi - Wiener Laboratories and the 77 cruzi indirect immunotluorescenc… | 2004 |
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.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
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. 2009, 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?
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…
Read the full statement (117 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072732: Ortho T. Cruzi Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072732
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026