Cleared Traditional

K093024 - YEAST TRAFFIC LIGHT PNA FISH (FDA 510(k) Clearance)

Class I Microbiology device.

K093024 · Advandx, Inc. · Microbiology device
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Jul 2010
Decision
289d
Days
Class 1
Risk

K093024 is an FDA 510(k) clearance for the YEAST TRAFFIC LIGHT PNA FISH. Classified as Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast (product code NZS), Class I - General Controls.

Submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on July 15, 2010 after a review of 289 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 K093024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date July 15, 2010
Days to Decision 289 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
187d slower than avg
Panel avg: 102d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NZS Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
Definition Indicated As A Qualitative Nucleic Acid Hybridization Assay Intended For Identification Of Candida Albicans From Blood Cultures With Yeast.
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.