# DEN120013: C. Difficile Nucleic Acid Amplification Test Assay

- Pathway: De Novo
- Applicant: unknown
- Decided: —
- Product code: OMN (C. Difficile Nucleic Acid Amplification Test Assay)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K123998: Quidel Molecular Direct C. Difficile Assay (2013), 2 descendants of its own
- K123355: Amplivue C. Difficile Assay (2012), 1 descendant of its own
- K171441: ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (2017), 0 descendants of its own
- K170491: Solana C. difficile Assay (2017), 0 descendants of its own
- K133936: Artus C. Difficile QS-RGQ MDX Kit (2014), 0 descendants of its own

Source page: https://510kreport.com/device/DEN120013
Methodology: https://510kreport.com/methodology