Cleared Traditional

K082068 - E. COLI PNA FISH

K082068 is an FDA 510(k) clearance for E. COLI PNA FISH, manufactured by Advandx, Inc.. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K082068 · Advandx, Inc. · Microbiology device
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Jun 2009
Decision
338d
Days
Class 1
Risk

K082068 is an FDA 510(k) clearance for the E. COLI PNA FISH. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on June 25, 2009 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K082068

510(k) Number K082068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2008
Decision Date June 25, 2009
Days to Decision 338 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
236d slower than avg
Panel avg: 102d · This submission: 338d
Pathway characteristics
Predicate-based equivalence.

JSS Device Classification - Class 1, General Controls

Product Code JSS Kit, Identification, Enterobacteriaceae
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 - JSS Kit, Identification, Enterobacteriaceae

All 33
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K082068.
GNR TRAFFIC LIGHT PNA FISH
K101558 · Advandx, Inc. · Dec 2010
E.COLI/P. AERUGINOSA PNA FISH
K092236 · Advandx, Inc. · Dec 2009
EK/P. AERUGINOSA PNA FISH
K092393 · Advandx, Inc. · Sep 2009
EK/P. AERUGINOSA PNA FISH
K081433 · Advandx, Inc. · Mar 2009
E.COLI/P. AERUGINOSA PNA FISH
K081309 · Advandx, Inc. · Dec 2008
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
K926002 · Alamar Biosciences Laboratory, Inc. · Sep 1993