FebriDx Bacterial / Non-bacterial Point of Care Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- FebriDx EUDAMED
- Device Name
- FebriDx Viral and Bacterial Immune Response Rapid Diagnostic Test EUDAMED
- Model / Reference
- CP0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850056728256 EUDAMED
- Basic UDI-DI
- B-00850056728256 EUDAMED
- 510(k) Number
- K230917 FDA 510(k)
- FDA Product Code
- QXA FDA 510(k)
- EMDN Code
- W0102160199 SPECIFIC PROTEINS RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3230 FDA 510(k)
- Regulation Number
- 866.3230 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
The FebriDx Bacterial / Non-bacterial Point of Care Assay is a lateral flow immunochromatography assay designed to detect host biomarkers for respiratory infections, distinguishing between bacterial and non-bacterial causes. It functions as a rapid diagnostic tool to aid in the differentiation of febrile illnesses, supporting clinical decision-making in microbiology settings. The assay leverages immunochromatographic technology to provide qualitative results within a short timeframe, enhancing point-of-care diagnostics.
This device is supplied as a single-use, non-sterile lateral flow test cassette intended for professional use in clinical or point-of-care environments. It is classified under FDA device class II and EU IVDD, with an FDA 510K clearance under K230917 and QXA product code. Storage and handling follow standard lateral flow assay protocols, and its regulatory status is confirmed through FDA 510K and EU In Vitro Diagnostic Directive compliance. No MRI safety considerations apply, as the device is non-electronic and non-metallic.
Frequently asked questions
What clinical scenarios is the FebriDx Bacterial / Non-bacterial Point of Care Assay intended to help differentiate in patients?
The FebriDx Assay is designed to help distinguish between bacterial and non-bacterial causes of respiratory infections in febrile patients. It aids clinicians in identifying whether a patient’s fever is likely due to a bacterial infection (such as strep throat or pneumonia) or a non-bacterial cause (like viral illness or other inflammatory conditions), supporting faster decision-making in microbiology settings.
How is the FebriDx Bacterial / Non-bacterial Point of Care Assay supplied, and is it meant for single or repeated use?
The FebriDx Assay is supplied as a single-use, non-sterile lateral flow test cassette. Each cassette is intended for one-time use by healthcare professionals in clinical or point-of-care environments, ensuring accuracy and preventing cross-contamination.
What type of technology does the FebriDx Assay use, and how quickly can results be expected?
The FebriDx Assay uses lateral flow immunochromatography technology to detect host biomarkers associated with respiratory infections. Results are qualitative and typically available within a short timeframe, making it suitable for rapid point-of-care diagnostics.
Are there any special storage or handling requirements for the FebriDx Assay beyond standard lateral flow assay protocols?
The FebriDx Assay follows standard storage and handling protocols for lateral flow assays. Since it is non-sterile and single-use, it should be stored according to manufacturer guidelines to maintain its integrity until use, but no additional specialized storage conditions are specified beyond typical environmental controls for diagnostic tests.
What regulatory pathways does the FebriDx Bacterial / Non-bacterial Point of Care Assay follow in the U.S. and Europe?
In the U.S., the FebriDx Assay has received FDA 510(k) clearance under K230917, classified as a Class II device under the product code QXA (Lateral Flow Immunochromatography Assay for Host Biomarkers of Respiratory Infection). In Europe, it complies with the In Vitro Diagnostic Directive (IVDD), confirming its regulatory compliance for use in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230917 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumos Diagnostics, Inc.
Sources (2)
- FDA 510(k) K230917 24 fields · synced Sep 18, 2026
- EUDAMED 5167b626-4ac3-42b8-a353-b5c309f2cc31 61 fields · synced Jul 24, 2026