Class Class II
BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954)
Description
BIOFIRE SPOTFIRE Respiratory (R) Panel by Biofire Diagnostics, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213954
Clearance Date2023-02-03
Clearance TypeDual Track
Product CodeQOF
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213954
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954) cites 0 predicate devices and is itself cited by 2 later devices.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024 |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Biofire Diagnostics, LLC | 2023 |
Trace the full predicate network for K213954
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.