Cleared Special

K042357 - IDI-MRSA ASSAY

K042357 is an FDA 510(k) clearance for IDI-MRSA ASSAY, manufactured by Infectio Diagnostic (I.D.I.), Inc.. The device is a Class 2 Microbiology device with product code NQX cleared through the Special 510(k) pathway after a 52-day FDA review.

K042357 · Infectio Diagnostic (I.D.I.), Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K042357

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 102d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

NQX Device Classification - Class 2, Special Controls

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 ASSAY
K080837 · Cepheid · Sep 2008
BD GENEOHM STAPHSR ASSAY
K071026 · Bd Diagnostics (Geneohm Sciences Canada, Inc) · Dec 2007
XPERT MRSA
K070462 · Cepheid · Apr 2007
IDI-MRSA
K033415 · Infectio Diagnostic (I.D.I.), Inc. · Mar 2004
K042357 · IDI-MRSA ASSAY
Download PDF FDA Summary Infectio Diagnostic (…