Cleared Traditional

JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (K072547) - FDA 510(k) Clearance

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

K072547 · Idaho Technology, Inc. · Microbiology device
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Dec 2007
Decision
100d
Days
Class 2
Risk

K072547 is an FDA 510(k) clearance for the JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124. Classified as Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit (product code OEH), Class II - Special Controls.

Submitted by Idaho Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 19, 2007 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Idaho Technology, Inc. devices

Submission Details

510(k) Number K072547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date December 19, 2007
Days to Decision 100 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
2d faster than avg
Panel avg: 102d · This submission: 100d
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.