510(k) · Cleared
Recalled · Class II · 2017Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiener Laboratories Saic · MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Cleared on Feb 11, 2004 after a 447-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 11, 2004
- Review
- 447 days
- Class
- Class I
- Product code
- MIU
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023889 Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat.…Wiener Laboratories Saic · 2004
- Descendant · cites it directly · 0 of its ownK072732 Ortho T. Cruzi Elisa Test SystemOrtho-Clinical Diagnostics, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K072732Ortho T. Cruzi Elisa Test SystemOrtho-Clinical Diagnostics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023889 | Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254 | Wiener Laboratories Saic | 2004 | — |
| +1 | K072732 | Ortho T. Cruzi Elisa Test System | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | — | MERIDIAN Chagas' IgG ELISA Named without a submission number | |
| * | — | ABBOTT Chagas Antibody EIA test system Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072732 | Ortho T. Cruzi Elisa Test System | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2017 | Class II | Z-0924-2018 | Nonconforming Material/Component | Internal program testing shows that product may not reach the indicated expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072732 (Ortho-Clinical Diagnostics, Inc., 2009) has gone furthest, with 0 descendants of its own.
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.
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 Wiener Laboratory enzyme-linked Immunosorbent assay (ELISA) recombinante V. 3.0 test system is a manual and automated (using the Biochem Immunosystems, Inc Labotech instrument) assay for the qualitative detection of total antibodies (IgG and IgM) to Trypanosoma cruzi in human serum and plasma (EDTA, heparin, or Citrate) using recombinant antigens of T. cruzi. Reactive assay results are presumptive evidence of present or past infection with Trypanosoma cruzi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023889: Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023889
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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