Cleared Special

K190771 - Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

K190771 is an FDA 510(k) clearance for Xpert MRSA/SA Blood Culture, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code NQX cleared through the Special 510(k) pathway after a 30-day FDA review.

K190771 · Cepheid · Microbiology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Apr 2019

Decision

30d

Days

Class 2

Risk

K190771 is an FDA 510(k) clearance for the Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s Syst.... Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 25, 2019 after a review of 30 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 - K190771

510(k) Number	K190771 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 2019
Decision Date	April 25, 2019
Days to Decision	30 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

72d faster than avg

Panel avg: 102d · This submission: 30d

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 K190771.

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 NxG

K162444 · Cepheid · Nov 2016

cobas MRSA/SA Test

K142721 · Roche Molecular Systems, Inc. · Dec 2014

BD MAX MRSA XT, BD MAX INSTRUMENT

K133605 · Geneohm Sciences Canada, Inc. · Dec 2013

FDA 510(k) Resources - Microbiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.