Cleared Traditional

K062461 - C. ALBICANS PNA FISH

K062461 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 JXB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K062461 · Advandx, Inc. · Microbiology device
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Oct 2006
Decision
63d
Days
Class 1
Risk

K062461 is an FDA 510(k) clearance for the C. ALBICANS PNA FISH. Classified as Kit, Identification, Yeast (product code JXB), Class I - General Controls.

Submitted by Advandx, Inc. (Canton, US). The FDA issued a Cleared decision on October 25, 2006 after a review of 63 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K062461

510(k) Number K062461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2006
Decision Date October 25, 2006
Days to Decision 63 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
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

JXB Device Classification - Class 1, General Controls

Product Code JXB Kit, Identification, Yeast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.

Regulatory Peers - JXB Kit, Identification, Yeast

All 11
Devices cleared under the same product code (JXB) and FDA review panel - the closest regulatory comparables to K062461.
YEAST TRAFFIC LIGHT PNA FISH
K080719 · Advandx, Inc. · Sep 2008
YEASTEST
K993554 · Diagnostic Markers, Inc. · Feb 2000
BACTICARD CANDIDA
K935124 · Remel Co. · Feb 1994
VITEK YEAST BIOCHEMICAL CARD
K881925 · Vitek Systems, Inc. · Jun 1988
YEAST IDENTIFICATION PANEL
K860575 · American Micro Scan · May 1986
YEAST IDENT
K830286 · Analytical Products, Inc. · Apr 1983