Cleared Traditional Expedited

JBAIDS ANTHRAC DETECTION SYSTEM (K051713) - FDA 510(k) Clearance

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

K051713 · Idaho Technology, Inc. · Microbiology device
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Nov 2005
Decision
144d
Days
Class 2
Risk

K051713 is an FDA 510(k) clearance for the JBAIDS ANTHRAC DETECTION SYSTEM. Classified as Assay, Nucleic Acid Amplification, Bacillus Anthracis (product code NHT), Class II - Special Controls.

Submitted by Idaho Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 144 days - within the typical 510(k) review window.

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: 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 K051713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date November 18, 2005
Days to Decision 144 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
42d slower than avg
Panel avg: 102d · This submission: 144d
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.