Cleared Traditional

K092655 - C. ALBICANS PNA FISH

K092655 is an FDA 510(k) clearance for C. ALBICANS PNA FISH, manufactured by Advandx, Inc.. The device is a Class 1 Microbiology device with product code NZS cleared through the Traditional 510(k) pathway after a 144-day FDA review.

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

FDA 510(k) Submission Details - K092655

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 102d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

NZS Device Classification - Class 1, General Controls

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.