510(k) · Cleared
ClearedDPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chembio Diagnostic Systems · QFO Zika Virus Serological Reagents
Cleared on Jun 3, 2020 as substantially equivalent to DEN180069 (InBios International, Inc., 2019) after a 93-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jun 3, 2020
- Review
- 93 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 deviceK200506 DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro…Chembio Diagnostic Systems · 2020
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) | K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | Chembio Diagnostic Systems | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 5…Clinical Use IV. Predicate Device: InBios ZIKV DetectTM 2.0 IgM Capture ELISA (DEN180069) 1 V.… | 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. 2020, 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?
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…
Read the full statement (416 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200506 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200506: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200506
Report an extraction error
Are you the manufacturer?
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