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510(k) K261475

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit by Biofire Defense, LLC — Product Code PMN

K261475 is an FDA 510(k) premarket notification submitted by Biofire Defense, LLC for the device "BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit". The FDA issued a decision of Substantially Equivalent on July 17, 2026. The device falls under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays), a Class II device regulated under 21 CFR 866.3920. Biofire Defense, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2026
Date Received
May 5, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Device Class
Class II
Regulation Number
866.3920
Review Panel
MI
Submission Type

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Other clearances by Biofire Defense, LLC

  • K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (March 12, 2025)
  • K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the (March 22, 2023)
  • K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fe (October 20, 2022)
  • K221460 — BioFire COVID-19 Test 2 (July 25, 2022)
  • K211079 — BioFire COVID-19 Test 2 (November 1, 2021)
  • DEN200043 — FilmArray Global Fever Panel (November 20, 2020)
  • K202382 — FilmArray Global Fever Panel External Control Kit (November 20, 2020)
  • K170883 — FilmArray NGDS Warrior Panel (June 22, 2017)
  • DEN160048 — FilmArray NGDS Warrior Panel (February 14, 2017)

Other clearances for product code PMN

  • K260577 — FilmArray TF Control Panel M527 (May 19, 2026)
  • K260041 — MDx-Chex for BCP (March 27, 2026)
  • K254166 — MDx-Chex for BCN (March 23, 2026)
  • K254167 — MDx-Chex for BCY (March 17, 2026)
  • K251526 — FilmArray GI Control Panel M238 (August 14, 2025)
  • K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (May 30, 2024)
  • K233611 — SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), (March 26, 2024)
  • K231221 — MDx-Chex for BC-GP (July 27, 2023)
  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP (April 13, 2023)

FDA data resources