510(k) K250768
K250768 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Anti-SARS-CoV-2". The FDA issued a decision of Substantially Equivalent on June 10, 2025. The device falls under product code QVP (Sars-Cov-2 Serology Test), a Class II device regulated under 21 CFR 866.3983. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2025
- Date Received
- March 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sars-Cov-2 Serology Test
- Device Class
- Class II
- Regulation Number
- 866.3983
- Review Panel
- MI
- Submission Type
A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.