De Novo · Granted
GrantedZIKV Detect 2.0 IgM Capture ELISA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InBios International, Inc. · QFO Zika Virus Serological Reagents
Granted on May 23, 2019 as a new device type through De Novo after a 148-day review. 3 later devices descend from it.
- Decided
- May 23, 2019
- Review
- 148 days
- Class
- Class II
- Product code
- QFO
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN180069 ZIKV Detect 2.0 IgM Capture ELISAInBios International, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200506 DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro…Chembio Diagnostic Systems · 2020
- Descendant · cites it directly · 0 of its ownK192046 LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II…DiaSorin, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191578 ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA…Siemens Healthcare Diagnostics, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic Systems · 2020 · cites it directly0descendants
- K192046LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetDiaSorin, Inc. · 2019 · cites it directly0descendants
- K191578ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50…Siemens Healthcare Diagnostics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019 | — |
| +1 | K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | Chembio Diagnostic Systems | 2020 | — |
| +1 | K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | DiaSorin, Inc. | 2019 | — |
| +1 | K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika… | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA De Novo 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 QFO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFO device
- #1 K200506 DPP Zika IgM System, DPP Zika IgM System…score -0.6 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | 2020 | 0 |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | 2019 | 0 |
| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50… | 2019 | 0 |
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?
- Of its descendants, K200506 (Chembio Diagnostic Systems, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QFO devicesQFO Zika Virus Serological Reagents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QFO
Too few QFO 510(k)s in any year since 2007 to give a median.
Recalls per year · QFO
No recall names QFO since 2007.
Adverse event reports per year · QFO
No MAUDE report names QFO since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 3 | — | 0 | 0 |
| 2020 | 1 | — | 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 ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission…
Read the full statement (227 words)
The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection, and may be detectable near day four post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
This assay is not indicated for testing blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180069 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180069: ZIKV Detect 2.0 IgM Capture ELISA.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180069
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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