Cleared Traditional

K131930 - JBAIDS ANTHRAX DETECTION KIT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131930 · Biofire Diagnostics, Inc. · Microbiology device
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Aug 2013
Decision
39d
Days
Class 2
Risk

K131930 is an FDA 510(k) clearance for the JBAIDS ANTHRAX DETECTION KIT. Classified as Assay, Nucleic Acid Amplification, Bacillus Anthracis (product code NHT), Class II - Special Controls.

Submitted by Biofire Diagnostics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 5, 2013 after a review of 39 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biofire Diagnostics, Inc. devices

Submission Details

510(k) Number K131930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date August 05, 2013
Days to Decision 39 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 102d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.