Cleared Traditional

K112937 - MRSA/SA ELITE MGB

K112937 is the FDA 510(k) clearance for MRSA/SA ELITE MGB by Elitech. It is a Class 2 Microbiology device (product code NQX) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K112937 · Elitech · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
242d
Days
Class 2
Risk

K112937 is an FDA 510(k) clearance for the MRSA/SA ELITE MGB. Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by Elitech (Bothell, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 242 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 Elitech devices

Submission Details

510(k) Number K112937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date June 01, 2012
Days to Decision 242 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
140d slower than avg
Panel avg: 102d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings.
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 - NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

All 14
Devices cleared under the same product code (NQX) and FDA review panel - the closest regulatory comparables to K112937.
Xpert MRSA NxG
K162444 · Cepheid · Nov 2016
cobas MRSA/SA Test
K142721 · Roche Molecular Systems, Inc. · Dec 2014
XPERT MRSA/SA BLOOD CULTURE ASSAY
K130894 · Cepheid · Jun 2013
NUCLISENS EASYQ MRSA
K102740 · bioMerieux, Inc. · May 2011
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
K101879 · Cepheid · Jul 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
K091409 · Roche Molecular Systems, Inc. · Jul 2010