# K253653: Xpert Hemorrhagic Fever

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Feb 20, 2026 after 92 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN150058 (2016). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel, Biofire Defense, LLC (2023) Summary page 8.

## Most influential descendants
- K261362: Xpert Hemorrhagic Fever (2026), 0 descendants of its own

## Indications for use
The Xpert Hemorrhagic Fever test, performed on the GeneXpert Edge X system, is an automated multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative in vitro detection and identification of RNA from multiple biothreat agents: • Ebola virus (including Zaire, Sudan, Taï Forest, and Bundibugyo, not differentiated) • Crimean-Congo hemorrhagic fever (CCHF) virus • Marburg virus • Lassa virus The Xpert Hemorrhagic Fever test uses EDTA-treated whole blood specimens collected by capillary or venous draw from individuals with signs and symptoms of the suspected infections and/or individuals who are at risk for exposure or may have been exposed to these agents. The Xpert Hemorrhagic Fever test is indicated as an aid in the diagnosis of viral hemorrhagic fevers and results should be used in conjunction with other clinical, epidemiologic and laboratory data in accordance with the guidelines provided by the Centers for Disease Control and Prevention (CDC) and United States Department of Defense (DoD). The Xpert Hemorrhagic Fever test results are for the presumptive identification of Ebola, CCHF, Marburg and Lassa viruses. Definitive identification requires additional testing and confirmation procedures in consultation with the appropriate public health authorities for whom reports may be necessary. Positive results do not rule out co-infection with organisms not included in the Xpert Hemorrhagic Fever test. The organism(s) detected may not be the definite cause of symptoms. Negative results do not preclude infection with these agents and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. The Xpert Hemorrhagic Fever test is for use only by United States Department of Defense laboratories having appropriate personal protective equipment (PPE) and other safety precautions including personnel trained in the safe handling of diagnostic clinical specimens potentially containing highly infectious agents. Viral hemorrhagic fevers are nationally notifiable diseases caused by biothreat agents and reporting of these diseases should be coordinated with the appropriate Department of Defense and public health authorities.

Source page: https://510kreport.com/device/K253653
Methodology: https://510kreport.com/methodology