# K200506: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

- Pathway: 510(k) (Traditional)
- Applicant: Chembio Diagnostic Systems
- Decided: Jun 3, 2020 after 93 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 5.

## Indications for use
DPP Zika IgM System The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated 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). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after symptom onset or after potential exposure as a sample collected earlier may return a negative result. If testing is needed after day 4 but before day 8 and results are negative, testing must be repeated one week later. 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 results. Zika IgM levels over the course of illness are not well characterized. Zika IgM levels are variable during the course of 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 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. The Chembio DPP Zika IgM System is not indicated for testing blood or plasma donors. The test cannot be visually interpreted by the operator and must be read on the DPP Micro Reader. DPP Zika IgM System Control Pack The Chembio DPP Zika IgM System Control Pack is an external quality control kit for use with the DPP Zika IgM System only. The performance characteristics of the DPP Zika IgM System Control Pack have not been established for any other assay or instrument different from the DPP Micro Reader. DPP Micro Reader The DPP Micro Reader is a reflectance reader used to obtain test results from DPP Zika IgM System. The DPP Micro Reader is necessary to minimize errors from direct visual interpretation; therefore, the results of DPP Zika IgM System cartridges must be read exclusively with the DPP Micro Reader.

Source page: https://510kreport.com/device/K200506
Methodology: https://510kreport.com/methodology