Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Summary
Ortho Clinical Diagnostics Inc. (QuidelOrtho) received 510(k) clearance for Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA, a PSZ device. Cleared on 2026-09-04.
Details
Source
510(k) Clearance
External ID
K254262
Action Date
2026-09-04
Status
Dual Track
Category
device
Product Code
PSZ
Product Description
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA. Product code: PSZ.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 445 device clearances issued this month. Ortho Clinical Diagnostics Inc. (QuidelOrtho) has received 3 total clearances in our database.
Ortho Clinical Diagnostics Inc. (QuidelOrtho) has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Ortho Clinical Diagnostics Inc. (QuidelOrtho) have FDA actions?
Ortho Clinical Diagnostics Inc. (QuidelOrtho) has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254262" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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