K200506 is an FDA 510(k) clearance for the DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader. This device is classified as a Zika Virus Serological Reagents (Class II - Special Controls, product code QFO).
Submitted by Chembio Diagnostic Systems (Medford, US). The FDA issued a Cleared decision on June 3, 2020, 93 days after receiving the submission on March 2, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3935. Zika Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Diagnosis Of Zika Virus Infection In Human Clinical Specimens From Individuals That Have Signs And Symptoms Consistent With Zika Virus Infection And/or Epidemiological Risk Factors. The Device Aids In The Presumptive Clinical Diagnosis Of Zika Virus Infection In Conjunction With Other Clinical And Laboratory Findings..
| 510(k) Number | K200506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | June 03, 2020 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QFO - Zika Virus Serological Reagents |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3935 |
| Definition | Zika Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Diagnosis Of Zika Virus Infection In Human Clinical Specimens From Individuals That Have Signs And Symptoms Consistent With Zika Virus Infection And/or Epidemiological Risk Factors. The Device Aids In The Presumptive Clinical Diagnosis Of Zika Virus Infection In Conjunction With Other Clinical And Laboratory Findings. |