Class Class II
QIAstat-Dx Respiratory Panel Mini (K242353)
Description
QIAstat-Dx Respiratory Panel Mini by QIAGEN GmbH, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242353
Clearance Date2024-10-25
Clearance TypeSpecial
Product CodeQOF
Regulation Number866.3981
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242353
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. QIAstat-Dx Respiratory Panel Mini (K242353) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233100 | QIAstat-Dx® Respiratory Panel Plus | QIAGEN GmbH | 2024 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory P... | QIAGEN GmbH | 2025 |
Trace the full predicate network for K242353
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.