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510(k) K071188

MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM by Idaho Technology, Inc. — Product Code NHT

K071188 is an FDA 510(k) premarket notification submitted by Idaho Technology, Inc. for the device "MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 21, 2007. The device falls under product code NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis), a Class II device regulated under 21 CFR 866.3045. Idaho Technology, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2007
Date Received
April 30, 2007
Clearance Type
Special
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 Idaho Technology, Inc.

  • K120267 — FILMARRAY RP PANEL (May 15, 2012)
  • K103207 — JBAIDS Q FEVER DETECTION KIT (May 20, 2011)
  • K110764 — FILMARRAY RP PANEL (April 27, 2011)
  • K103175 — FILMARRAY RESPIRATORY PANEL (RP) (February 17, 2011)
  • K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (December 20, 2007)
  • K072547 — JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (December 19, 2007)
  • K051713 — JBAIDS ANTHRAC DETECTION SYSTEM (November 18, 2005)

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)
  • K131930 — JBAIDS ANTHRAX DETECTION KIT (August 5, 2013)
  • K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (December 20, 2007)
  • K051713 — JBAIDS ANTHRAC DETECTION SYSTEM (November 18, 2005)

FDA data resources