Elecsys Anti-SARS-CoV-2
FDA 510(k) K250768 · Roche Diagnostics
510(k) numberK250768
Submission
- Device name
- Elecsys Anti-SARS-CoV-2
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- March 13, 2025
- Decision date
- June 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QVP – Sars-Cov-2 Serology Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3983
- Specialty
- Microbiology
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…
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Questions and answers
When was Elecsys Anti-SARS-CoV-2 cleared by the FDA?
Elecsys Anti-SARS-CoV-2 (K250768) received a 510(k) decision of Substantially Equivalent on June 10, 2025, 89 days after the submission was received.
What is the product code of K250768?
The FDA product code is QVP – Sars-Cov-2 Serology Test, a Class II (moderate risk) device regulated under 21 CFR 866.3983.