Cleared Special

K071188 - MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM

K071188 is an FDA 510(k) clearance for MODIFICATION TO JBAIDS ANTHRAX DETECTIO..., manufactured by Idaho Technology, Inc.. The device is a Class 2 Microbiology device with product code NHT cleared through the Special 510(k) pathway after a 21-day FDA review.

K071188 · Idaho Technology, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
21d
Days
Class 2
Risk

K071188 is an FDA 510(k) clearance for the MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM. Classified as Assay, Nucleic Acid Amplification, Bacillus Anthracis (product code NHT), Class II - Special Controls.

Submitted by Idaho Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 21, 2007 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3045 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071188

510(k) Number K071188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date May 21, 2007
Days to Decision 21 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

NHT Device Classification - Class 2, Special Controls

Product Code NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3045
Definition An Invitro Diagnostic Device Used To Presumptively Detect The Presence Or Absence Of B. Anthracis Directly In Blood Specimens Or Suspicious Culture Growth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis

Devices cleared under the same product code (NHT) and FDA review panel - the closest regulatory comparables to K071188.
ANTHRACIS REAL-TIME PCR ASSAY
K140426 · Centers For Disease Control and Prevention (Cdc) · May 2014
JBAIDS ANTHRAX DETECTION KIT
K131930 · Biofire Diagnostics, Inc. · Aug 2013
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
K072631 · Idaho Technology, Inc. · Dec 2007
JBAIDS ANTHRAC DETECTION SYSTEM
K051713 · Idaho Technology, Inc. · Nov 2005
K071188 · MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
Download PDF FDA Summary Idaho Technology, Inc.