Home / 510(k) Clearances / K131930

510(k) K131930

JBAIDS ANTHRAX DETECTION KIT by Biofire Diagnostics, Inc. — Product Code NHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2013
Date Received
June 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Nucleic Acid Amplification, Bacillus Anthracis
Device Class
Class II
Regulation Number
866.3045
Review Panel
MI
Submission Type

An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.

Other clearances by Biofire Diagnostics, Inc.

  • K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (August 14, 2025)
  • K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (January 16, 2025)
  • K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RF (December 20, 2024)
  • K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (November 7, 2024)
  • K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (May 30, 2024)
  • K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (March 26, 2024)
  • K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (April 13, 2023)
  • K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (March 16, 2023)
  • K213954 — BIOFIRE SPOTFIRE Respiratory (R) Panel (February 3, 2023)
  • K222601 — FilmArray Pneumonia Panel plus (October 27, 2022)

Other clearances for product code NHT

  • K192871 — B. anthracis Real-time PCR Assay (November 7, 2019)
  • K140426 — ANTHRACIS REAL-TIME PCR ASSAY (May 22, 2014)
  • K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (December 20, 2007)
  • K071188 — MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM (May 21, 2007)
  • K051713 — JBAIDS ANTHRAC DETECTION SYSTEM (November 18, 2005)