K192046 is an FDA 510(k) clearance for the LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set. This device is classified as a Zika Virus Serological Reagents (Class II - Special Controls, product code QFO).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on October 28, 2019, 89 days after receiving the submission on July 31, 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 | K192046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2019 |
| Decision Date | October 28, 2019 |
| Days to Decision | 89 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. |