Cleared Traditional

K140426 - ANTHRACIS REAL-TIME PCR ASSAY (FDA 510(k) Clearance)

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

K140426 · Centers For Disease Control and Prevention (Cdc) · Microbiology device
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May 2014
Decision
92d
Days
Class 2
Risk

K140426 is an FDA 510(k) clearance for the ANTHRACIS REAL-TIME PCR ASSAY. Classified as Assay, Nucleic Acid Amplification, Bacillus Anthracis (product code NHT), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Cdc) (Atlanta, US). The FDA issued a Cleared decision on May 22, 2014 after a review of 92 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 Centers For Disease Control and Prevention (Cdc) devices

Submission Details

510(k) Number K140426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2014
Decision Date May 22, 2014
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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.