DEN180069 is an FDA 510(k) submission for the ZIKV Detect 2.0 IgM Capture ELISA. This device is classified as a Zika Virus Serological Reagents (Class II - Special Controls, product code QFO).
Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Not Cleared (DENG) decision on May 23, 2019.
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 | DEN180069 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 26, 2018 |
| Decision Date | May 23, 2019 |
| Days to Decision | 148 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| 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. |