Cleared Special

IDI-MRSA ASSAY (K042357) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042357 · Infectio Diagnostic (I.D.I.), Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
52d
Days
Class 2
Risk

K042357 is an FDA 510(k) clearance for the IDI-MRSA ASSAY. Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by Infectio Diagnostic (I.D.I.), Inc. (Hydes, US). The FDA issued a Cleared decision on October 22, 2004 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Infectio Diagnostic (I.D.I.), Inc. devices

Submission Details

510(k) Number K042357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date October 22, 2004
Days to Decision 52 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 102d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

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 23
Devices cleared under the same product code (NQX) and FDA review panel - the closest regulatory comparables to K042357.
Xpert MRSA/SA SSTI
K243625 · Cepheid · Dec 2024
Xpert® SA Nasal Complete
K243070 · Cepheid · Oct 2024
ARIES MRSA Assay
K191742 · Luminex Corporation · Sep 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
K190771 · Cepheid · Apr 2019
NUCLISENS EASYQ MRSA
K102740 · bioMerieux, Inc. · May 2011