Cleared Traditional

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS (K051794) - FDA 510(k) Clearance

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

K051794 · Office of the Surgeon General, U.S. Army · Microbiology device
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Aug 2005
Decision
46d
Days
Class 2
Risk

K051794 is an FDA 510(k) clearance for the GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS. Classified as Bacteriophage And Controls, B. Anthracis Lysis (product code NVQ), Class II - Special Controls.

Submitted by Office of the Surgeon General, U.S. Army (Fort Detrick, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Office of the Surgeon General, U.S. Army devices

Submission Details

510(k) Number K051794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date August 16, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 102d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.