Cleared Traditional

K102740 - NUCLISENS EASYQ MRSA

Also marketed or referenced as:
NUCLISENS EASYQ ANALYZER NUCLISENS EASYQ INCUBATOR (110 VOLT) NUCLISENS DIRECTOR V.2.6

K102740 is the FDA 510(k) clearance for NUCLISENS EASYQ MRSA by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code NQX) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K102740 · bioMerieux, Inc. · Microbiology device
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May 2011
Decision
240d
Days
Class 2
Risk

K102740 is an FDA 510(k) clearance for the NUCLISENS EASYQ MRSA. Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 240 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K102740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date May 20, 2011
Days to Decision 240 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 102d · This submission: 240d
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 13
Devices cleared under the same product code (NQX) and FDA review panel - the closest regulatory comparables to K102740.
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LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
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XPERT MRSA/SA NASAL ASSAY
K100822 · Cepheid · Jun 2010