Cleared Traditional

K060099 - S. AUREUS PNA FISH (FDA 510(k) Clearance)

Class I Microbiology device.

K060099 · Advandx, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
115d
Days
Class 1
Risk

K060099 is an FDA 510(k) clearance for the S. AUREUS PNA FISH. 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. (Canton, US). The FDA issued a Cleared decision on May 8, 2006 after a review of 115 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

Submission Details

510(k) Number K060099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date May 08, 2006
Days to Decision 115 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
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.