Cleared Traditional

K092393 - EK/P. AERUGINOSA PNA FISH (FDA 510(k) Clearance)

Class I Microbiology device.

K092393 · Advandx, Inc. · Microbiology device
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Sep 2009
Decision
27d
Days
Class 1
Risk

K092393 is an FDA 510(k) clearance for the EK/P. AERUGINOSA PNA FISH. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on September 1, 2009 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Advandx, Inc. devices

Submission Details

510(k) Number K092393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date September 01, 2009
Days to Decision 27 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
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.