Cleared Traditional

K230440 - Xpert® Xpress CoV-2 plus (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230440 · Cepheid · Microbiology device
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Oct 2023
Decision
234d
Days
Class 2
Risk

K230440 is an FDA 510(k) clearance for the Xpert® Xpress CoV-2 plus. Classified as Respiratory Specimen Nucleic Acid Sars-cov-2 Test (product code QQX), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on October 13, 2023 after a review of 234 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - 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 Cepheid devices

Submission Details

510(k) Number K230440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date October 13, 2023
Days to Decision 234 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
132d slower than avg
Panel avg: 102d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3981
Definition A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Sars-cov-2 That Cause Covid-19 Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 Nucleic Acid Targets In Human Clinical Respiratory Specimens From Patients Suspected Of Covid-19 Based On Signs And Symptoms Of Respiratory Infections By Their Healthcare Providers. The Device Is Intended To Aid In The Diagnosis Of Covid-19 In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.
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 - QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test

All 10
Devices cleared under the same product code (QQX) and FDA review panel - the closest regulatory comparables to K230440.
Aptima SARS-CoV-2 Assay
K243396 · Hologic, Inc. · Feb 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K240867 · Roche Molecular Systems, Inc. · Feb 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
K242109 · Cepheid · Jan 2025
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · Abbott Molecular · Dec 2024
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
K233453 · Life Technologies Corporation · Jul 2024
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · Roche Molecular Systems, Inc. · Jun 2023