Cleared Traditional

K123418 - GRAM-NEGATIVE QUICKFISH BC

K123418 is the FDA 510(k) clearance for GRAM-NEGATIVE QUICKFISH BC by Advandx, Inc.. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K123418 · Advandx, Inc. · Microbiology device
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Jul 2013
Decision
257d
Days
Class 1
Risk

K123418 is an FDA 510(k) clearance for the GRAM-NEGATIVE QUICKFISH BC. 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 July 21, 2013 after a review of 257 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

Submission Details

510(k) Number K123418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2012
Decision Date July 21, 2013
Days to Decision 257 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
155d slower than avg
Panel avg: 102d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 21
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K123418.
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