Cleared Traditional

K072547 - JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124

K072547 is an FDA 510(k) clearance for JBAIDS TULAREMIA DETECTION KIT, manufactured by Idaho Technology, Inc.. The device is a Class 2 Microbiology device with product code OEH cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

FDA 510(k) Submission Details - K072547

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.

OEH Device Classification - Class 2, Special Controls

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.