Cleared Traditional

K101558 - GNR TRAFFIC LIGHT PNA FISH

K101558 is an FDA 510(k) clearance for GNR TRAFFIC LIGHT 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 195-day FDA review.

K101558 · Advandx, Inc. · Microbiology device
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Dec 2010
Decision
195d
Days
Class 1
Risk

K101558 is an FDA 510(k) clearance for the GNR TRAFFIC LIGHT 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 December 16, 2010 after a review of 195 days - an extended review 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: 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 - K101558

510(k) Number K101558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date December 16, 2010
Days to Decision 195 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
93d slower than avg
Panel avg: 102d · This submission: 195d
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 K101558.
hemoFISH Masterpanel
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K123418 · Advandx, Inc. · Jul 2013
E.COLI/P. AERUGINOSA PNA FISH
K092236 · Advandx, Inc. · Dec 2009
EK/P. AERUGINOSA PNA FISH
K092393 · Advandx, Inc. · Sep 2009
E. COLI PNA FISH
K082068 · Advandx, Inc. · Jun 2009
EK/P. AERUGINOSA PNA FISH
K081433 · Advandx, Inc. · Mar 2009