Cleared Traditional

K131729 - JBAIDS PLAGUE DETECTION KIT (FDA 510(k) Clearance)

K131729 · Biofire Diagnostics, Inc. · Microbiology device
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Jul 2013
Decision
49d
Days
-
Risk

K131729 is an FDA 510(k) clearance for the JBAIDS PLAGUE DETECTION KIT. Classified as Yersinia Spp. Reagents (product code OIH).

Submitted by Biofire Diagnostics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 31, 2013 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel. 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 K131729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2013
Decision Date July 31, 2013
Days to Decision 49 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
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OIH Yersinia Spp. Reagents
Device Class -
Definition Yersinia Spp. Reagents Are Devices That Consist Of Serological Reagents And Nucleic Acid Amplification Reagents To Differentiate Yersinia Spp. And Presumptively Identify Yersinia Pestis (y. Pestis) From Cultured Isolates Or Clinical Specimens. They Are Indicated For Use As An Aid In The Laboratory Of Diagnosis Of Plague.