DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200506 FDA 510(k)
- FDA Product Code
- QFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3935 FDA 510(k)
- Regulation Number
- 866.3935 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DPP Zika IgM System is a rapid test for detecting Zika virus infection using venous whole blood, serum, or plasma. It provides results in as little as 15 minutes and detects Zika virus IgM antibodies from 8 days up to 12 weeks after illness/symptom onset.
The system includes the DPP Zika IgM System Control Pack and uses the DPP Micro Reader for objective results. It is designed for fingerstick whole blood, EDTA venous whole blood, EDTA plasma, and serum samples. The device has received FDA 510(k) clearance with the product code QFO and is classified as a Class 2 device for Zika Virus Serological Reagents.
Frequently asked questions
What is the purpose of the DPP Zika IgM System?
The DPP Zika IgM System is a rapid test designed to detect Zika virus infection by identifying Zika virus IgM antibodies in venous whole blood, serum, or plasma samples, providing results in as little as 15 minutes.
What types of samples can be used with the DPP Zika IgM System?
The system accepts fingerstick whole blood, EDTA venous whole blood, EDTA plasma, and serum samples for testing Zika virus IgM antibodies.
How long after symptom onset can the DPP Zika IgM System detect Zika virus?
The test can detect Zika virus IgM antibodies from 8 days up to 12 weeks after illness or symptom onset.
What components are included in the DPP Zika IgM System?
The system includes the DPP Zika IgM System, the DPP Zika IgM System Control Pack, and uses the DPP Micro Reader for objective result interpretation.
What is the regulatory classification of the DPP Zika IgM System?
The device has received FDA 510(k) clearance with product code QFO and is classified as a Class 2 device for Zika Virus Serological Reagents.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DPP® Zika IgM Assay USA - Chembio Diagnostics, Inc., DPP® Zika IgM/IgG System International - Chembio Diagnostics, Inc., Chembio DPP Zika IgM Assay System 20 | Buy Online | Chembio | Fisher ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200506 | Class II | Active |
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Manufacturer
- Manufacturer
- Chembio Diagnostic Systems
Sources (1)
- FDA 510(k) K200506 24 fields · synced Sep 19, 2026