Sofia Lyme FIA; Sofia 2 Campylobacter FIA
Summary
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) received 510(k) clearance for Sofia Lyme FIA; Sofia 2 Campylobacter FIA, a LSR device. Cleared on 2026-07-10.
Details
Source
510(k) Clearance
External ID
K254295
Action Date
2026-07-10
Status
Traditional
Category
device
Product Code
LSR
Product Description
Sofia Lyme FIA; Sofia 2 Campylobacter FIA. Product code: LSR.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 452 device clearances issued this month.
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?
This is the only FDA action we have on record for Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254295" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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