510(k) · Cleared
ClearedADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · QFO Zika Virus Serological Reagents
Cleared on Jul 17, 2019 as substantially equivalent to DEN180069 (InBios International, Inc., 2019) after a 33-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jul 17, 2019
- Review
- 33 days
- Class
- Class II
- Product code
- QFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180069 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180069 ZIKV Detect 2.0 IgM Capture ELISAInBios International, Inc. · 2019
- This deviceK191578 ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA…Siemens Healthcare Diagnostics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019 | — |
| 0 (this device) | K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika… | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
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 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISASummary page 4…Microbiology (83) 4. Predicate Device Information Predicate Device Name: ZIKV Detect 2.0 IgM Capture ELISA De Novo Request Number: DEN180069 Siemens Healthcare Diagnostics Inc., Tarrytown, NY Page 1 of 12 ADVIA Centaur Zika… | 2019 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN180069.
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 ADVIA Centaur Zika test is for in vitro diagnostic use in the qualitative detection of IgM antibodies to the Zika virus in human serum and plasma (potassium EDTA or lithium heparin) specimens using the ADVIA Centaur XP and ADVIA Centaur XPT systems. The ADVIA Centaur Zika test is intended for the presumptive clinical laboratory diagnosis of Zika virus infection. The test is intended for use only in individuals (children, adolescents and adults…
Read the full statement (253 words)
The ADVIA Centaur Zika test is for in vitro diagnostic use in the qualitative detection of IgM antibodies to the Zika virus in human serum and plasma (potassium EDTA or lithium heparin) specimens using the ADVIA Centaur XP and ADVIA Centaur XPT systems.
The ADVIA Centaur Zika test is intended for the presumptive clinical laboratory diagnosis of Zika virus infection. The test is intended for use only in individuals (children, adolescents and adults, including pregnant women) with clinical signs and symptoms consistent with Zika virus infection, and/or meeting the CDC Zika virus epidemiological criteria (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). 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 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day 4 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.
The ADVIA Centaur Zika test is not indicated for testing blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191578: ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191578
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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