# DEN180069: ZIKV Detect 2.0 IgM Capture ELISA

- Pathway: De Novo (Direct)
- Applicant: InBios International, Inc.
- Decided: May 23, 2019 after 148 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K200506: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (2020), 0 descendants of its own
- K192046: LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (2019), 0 descendants of its own
- 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 (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN180069
Methodology: https://510kreport.com/methodology