FebriDx Bacterial/Non-bacterial Assay
Summary
Lumos Diagnostics, Inc. received 510(k) clearance for FebriDx Bacterial/Non-bacterial Assay, a QXA device. Cleared on 2026-03-24.
Details
Source
510(k) Clearance
External ID
K260787
Action Date
2026-03-24
Status
Dual Track
Category
device
Product Code
QXA
Product Description
FebriDx Bacterial/Non-bacterial Assay. Product code: QXA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Lumos Diagnostics, Inc. has received 2 total clearances in our database.
Lumos Diagnostics, Inc. has 2 FDA actions in our database, including 2 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 Lumos Diagnostics, Inc. have FDA actions?
Lumos Diagnostics, Inc. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260787" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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