# 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

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 17, 2019 after 33 days
- Product code: QFO (Zika Virus Serological Reagents)
- Device class: 2
- Regulation: 21 CFR 866.3935
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180069 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180069: ZIKV Detect 2.0 IgM Capture ELISA, InBios International, Inc. (2019) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K191578
Methodology: https://510kreport.com/methodology