Cleared Special

K143592 - GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K143592 · The Surgeon General, Department of the Army · Microbiology device
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Apr 2015
Decision
119d
Days
Class 2
Risk

K143592 is an FDA 510(k) clearance for the GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC. Classified as Bacteriophage And Controls, B. Anthracis Lysis (product code NVQ), Class II - Special Controls.

Submitted by The Surgeon General, Department of the Army (Fort Detrick, US). The FDA issued a Cleared decision on April 16, 2015 after a review of 119 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all The Surgeon General, Department of the Army devices

Submission Details

510(k) Number K143592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date April 16, 2015
Days to Decision 119 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 102d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NVQ Bacteriophage And Controls, B. Anthracis Lysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3045
Definition A Gamma Phage Lysis Assay Intended For The Identification Of Bacillus Anthracis From Non-hemolytic, Aerobic Gram Positive Colonies Isolated From Sheep Blood Agar. To Aid In The Laboratory Identification Of Bacillus Anthracis Culture Growth By Lysis With A Specific Bacteriophage.
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.