Cleared Traditional

K092655 - C. ALBICANS PNA FISH (FDA 510(k) Clearance)

Class I Microbiology device.

K092655 · Advandx, Inc. · Microbiology device
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Jan 2010
Decision
144d
Days
Class 1
Risk

K092655 is an FDA 510(k) clearance for the C. ALBICANS 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 January 19, 2010 after a review of 144 days - within the typical 510(k) review window.

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 K092655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2009
Decision Date January 19, 2010
Days to Decision 144 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
42d slower than avg
Panel avg: 102d · This submission: 144d
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.