Cleared Traditional

K092166 - S. AUREUS/CNS PNA FISH, MODEL KT005

K092166 is an FDA 510(k) clearance for S. AUREUS/CNS PNA FISH, manufactured by Advandx, Inc.. The device is a Class 1 Microbiology device with product code NXX cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K092166 · Advandx, Inc. · Microbiology device
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Nov 2009
Decision
125d
Days
Class 1
Risk

K092166 is an FDA 510(k) clearance for the S. AUREUS/CNS PNA FISH, MODEL KT005. Classified as Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus (product code NXX), Class I - General Controls.

Submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on November 23, 2009 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3700 - 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

FDA 510(k) Submission Details - K092166

510(k) Number K092166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date November 23, 2009
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 102d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

NXX Device Classification - Class 1, General Controls

Product Code NXX Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3700
Definition The S. Aureus Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For Presumptive Identification Of Staphylococcus Aureus From Blood Cultures With Gram-positive Cocci In Clusters (gpcc). This Device Is Not Exempt Per 21 Cfr Part 866.9(c)(6).
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.