510(k) · Cleared
ClearedXpert Hemorrhagic Fever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Cleared on Aug 7, 2026 as substantially equivalent to K253653 (Cepheid, 2026) after a 102-day review. Its family tree reaches back 6 generations to 2016.
- Decided
- Aug 7, 2026
- Review
- 102 days
- Class
- Class II
- Product code
- QVR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN150058 (2016). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 5 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 4 generations backK163522 FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017
- 3 generations backK202382 FilmArray Global Fever Panel External Control KitBiofire Defense, LLC · 2020
- 2 generations backK213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control…Biofire Defense, LLC · 2023
- 1 generation backK253653 Xpert Hemorrhagic FeverCepheid · 2026
- This deviceK261362 Xpert Hemorrhagic FeverCepheid · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −5 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −4 | K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017 | — |
| −3 | K202382 | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | 2020 | — |
| −2 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for… | Biofire Defense, LLC | 2023 | — |
| −1 | K253653 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
| 0 (this device) | K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QVR device
- #1 K213362 BioFire Global Fever Special Pathogens Panel…score 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K253653 | Xpert Hemorrhagic FeverSummary page 6…OOI Classification Advisory Microbiology (83) Panel Prescription Use Yes Predicate Device Assay Xpert Hemorrhagic Fever (K253653) 510(k) Summary Page 1 of 23 1.1. Devi… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All QVR devicesQVR Multiplex Nucleic Acid Detection System For Biothreat Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QVR
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVR
Too few QVR 510(k)s in any year since 2007 to give a median.
Recalls per year · QVR
No recall names QVR since 2007.
Adverse event reports per year · QVR
No MAUDE report names QVR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (323 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261362: Xpert Hemorrhagic Fever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261362
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026