BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
FDA 510(k) K220870 · Biofire Defense, LLC
Submission
- Device name
- BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
- Applicant
- Biofire Defense, LLC
Salt Lake City, UT, US - Received
- March 25, 2022
- Decision date
- October 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QMV – Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3966
- Specialty
- Microbiology
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis…
Other 510(k)s with product code QMV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243463 | BIOFIRE FILMARRAY Tropical Fever PanelQMV · Special | Biofire Diagnostics, LLC (Biomerieux) | 12/05/2024SE |
More from Biofire Diagnostics, LLC (Biomerieux)
| 510(k) | Device | Decision |
|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional | 07/17/2026SE |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control KitPRD · Traditional | 03/12/2025SE |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…QVR · Traditional | 03/22/2023SE |
| K221460 | BioFire COVID-19 Test 2QQX · Special | 07/25/2022SE |
| K211079 | BioFire COVID-19 Test 2QQX · Traditional | 11/01/2021SE |
| K202382 | FilmArray Global Fever Panel External Control KitPMN · Traditional | 11/20/2020SE |
| K170883 | FilmArray NGDS Warrior PanelPRD · Traditional | 06/22/2017SE |
Questions and answers
When was BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel cleared by the FDA?
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (K220870) received a 510(k) decision of Substantially Equivalent on October 20, 2022, 209 days after the submission was received.
What is the product code of K220870?
The FDA product code is QMV – Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness, a Class II (moderate risk) device regulated under 21 CFR 866.3966.