Cleared Traditional

K123753 - IMDX VANR FOR ABBOTT M2000 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123753 · Intelligent Medical Devices, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
223d
Days
Class 2
Risk

K123753 is an FDA 510(k) clearance for the IMDX VANR FOR ABBOTT M2000. Classified as System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (product code NIJ), Class II - Special Controls.

Submitted by Intelligent Medical Devices, Inc. (Beverly, US). The FDA issued a Cleared decision on July 17, 2013 after a review of 223 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Intelligent Medical Devices, Inc. devices

Submission Details

510(k) Number K123753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2012
Decision Date July 17, 2013
Days to Decision 223 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 102d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition The In Vitro Device Is Intended To Detect The Presence Of The Vana And Vanb Genes In Isolated Colonies Of Enterococcus Spp. As A Marker For Vancomycin Resistance Using Dna Probe Technology
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Devices cleared under the same product code (NIJ) and FDA review panel - the closest regulatory comparables to K123753.
Xpert vanA
K243405 · Cepheid · Nov 2024