Cleared Special

K243405 - Xpert vanA

K243405 is an FDA 510(k) clearance for Xpert vanA, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code NIJ cleared through the Special 510(k) pathway after a 20-day FDA review.

K243405 · Cepheid · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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Nov 2024
Decision
20d
Days
Class 2
Risk

K243405 is an FDA 510(k) clearance for the Xpert vanA. Classified as System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (product code NIJ), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on November 21, 2024 after a review of 20 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 - K243405

510(k) Number K243405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2024
Decision Date November 21, 2024
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

NIJ Device Classification - Class 2, Special Controls

Product Code NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition The In Vitro Device Is Intended To Detect The Presence Of The Vana And Vanb Genes In Isolated Colonies Of Enterococcus Spp. As A Marker For Vancomycin Resistance Using Dna Probe Technology
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 - NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Devices cleared under the same product code (NIJ) and FDA review panel - the closest regulatory comparables to K243405.
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K061686 · Geneohm Sciences Canada, Inc. · Aug 2006
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
K020576 · Id Biomedical Corp. · May 2002
K243405 · Xpert vanA
Download PDF FDA Summary Cepheid