Cleared Traditional

K131936 - JBAIDS TULAREMIA DETECTION KIT (FDA 510(k) Clearance)

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

K131936 · Biofire Diagnostics, Inc. · Microbiology device
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Jul 2013
Decision
34d
Days
Class 2
Risk

K131936 is an FDA 510(k) clearance for the JBAIDS TULAREMIA DETECTION KIT. Classified as Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit (product code OEH), Class II - Special Controls.

Submitted by Biofire Diagnostics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 31, 2013 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3280 - 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 K131936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date July 31, 2013
Days to Decision 34 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
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEH Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3280
Definition To Aid In The Diagnosis Of Individuals Presenting With Signs And Symptoms Of Pneumonic Or Typhoidal Tularemia With A Qualitative In Vitro Diagnostic (ivd) Detection Of Target Dna Sequences Of Francisella Tularensis.
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.