DeviceSignal · 510(k) cleared
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
FDA 510(k) decision recorded 2026-09-04 · K254264 · Dual Track 510(k)
Event510(k) cleared
Effective2026-09-04
DecisionSESE
On 2026-09-04 the FDA recorded a 510(k) clearance decision for Ortho-Clinical Diagnostics, Inc. (QuidelOrtho), for Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA. Clearance K254264. Product code QVF. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K254264
- Applicant
- Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Device
- Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
- Decided on
- 2026-09-04
- Received on
- 2025-12-30
- Decision
- SESE
- Clearance type
- Dual Track
- Product code
- QVF
- Review days
- 248
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K254264- Snapshot hash
20a5eca6af1b369a7deac34e4dde0974506cc835c24e3cb66b330d9671a11814- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
6465e6de10cd655fd6e10d61bd3f22affb14fa88ba1515030804572f077b002a- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)