FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys Anti-SARS-CoV-2
K Number: K253839
·
Decision Dec 17, 2025
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
4
Applicant Total
183
Review Days
16
Basic Information
- Device Name
- Elecsys Anti-SARS-CoV-2
- K Number
- K253839
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3983
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- December 1, 2025
- Decision Date
- December 17, 2025
- Product Code
- QVP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QVP | Sars-Cov-2 Serology Test | FDA class 2 | Microbiology |
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Other Clearances by Roche Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | Jun 12, 2026 | Substantially Equivalent |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Apr 13, 2026 | Substantially Equivalent |
| K260048 | Elecsys Anti-HAV IgM | Apr 7, 2026 | Substantially Equivalent |
| K260049 | Elecsys Anti-HBc IgM | Apr 7, 2026 | Substantially Equivalent |
| K260046 | Elecsys Anti-HBc II | Apr 7, 2026 | Substantially Equivalent |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Apr 2, 2026 | Substantially Equivalent |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253188 | CoaguChek XS Plus System | Oct 24, 2025 | Substantially Equivalent |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Oct 8, 2025 | Substantially Equivalent |