# DEN130032: Xpert MTB/Rif Assay

- Pathway: De Novo (Direct)
- Applicant: Cepheid
- Decided: Jul 25, 2013 after 44 days
- Product code: PEU (System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.3373
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K143302: Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (2015), 0 descendants of its own

Source page: https://510kreport.com/device/DEN130032
Methodology: https://510kreport.com/methodology