K191578 is an FDA 510(k) clearance for the ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control. This device is classified as a Zika Virus Serological Reagents (Class II - Special Controls, product code QFO).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 17, 2019, 33 days after receiving the submission on June 14, 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 | K191578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2019 |
| Decision Date | July 17, 2019 |
| Days to Decision | 33 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. |