Cleared Traditional

K081309 - E.COLI/P. AERUGINOSA PNA FISH (FDA 510(k) Clearance)

Class I Microbiology device.

K081309 · Advandx, Inc. · Microbiology device
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Dec 2008
Decision
224d
Days
Class 1
Risk

K081309 is an FDA 510(k) clearance for the E.COLI/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 December 19, 2008 after a review of 224 days - an extended review 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: 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 Advandx, Inc. devices

Submission Details

510(k) Number K081309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2008
Decision Date December 19, 2008
Days to Decision 224 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
122d slower than avg
Panel avg: 102d · This submission: 224d
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.