Cleared Traditional

K063127 - ENTEROCOCCUS FAECALIS PNA FISH (FDA 510(k) Clearance)

Class I Microbiology device.

K063127 · Advandx, Inc. · Microbiology device
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Dec 2006
Decision
70d
Days
Class 1
Risk

K063127 is an FDA 510(k) clearance for the ENTEROCOCCUS FAECALIS PNA FISH. Classified as Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (product code OAH), Class I - General Controls.

Submitted by Advandx, Inc. (Canton, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advandx, Inc. devices

Submission Details

510(k) Number K063127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2006
Decision Date December 22, 2006
Days to Decision 70 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
32d faster than avg
Panel avg: 102d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OAH Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
Definition E. Faecalis Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For The Identification Of Enterococcus Faecalis And Other Enterococci (oe) From Blood Cultures Showing Gram-positive Cocci In Pairs And Chains.
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.