Cleared Traditional

K240867 - cobas SARS-CoV-2 Qualitative for use on...

K240867 is an FDA 510(k) clearance for cobas SARS-CoV-2 Qualitative for use on..., manufactured by Roche Molecular Systems, Inc.. The device is a Class 2 Microbiology device with product code QQX cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K240867 · Roche Molecular Systems, Inc. · Microbiology device
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Feb 2025
Decision
319d
Days
Class 2
Risk

K240867 is an FDA 510(k) clearance for the cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems. Classified as Respiratory Specimen Nucleic Acid Sars-cov-2 Test (product code QQX), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 11, 2025 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Roche Molecular Systems, Inc. devices

FDA 510(k) Submission Details - K240867

510(k) Number K240867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2024
Decision Date February 11, 2025
Days to Decision 319 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
217d slower than avg
Panel avg: 102d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QQX Device Classification - Class 2, Special Controls

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 K240867.
Aptima SARS-CoV-2 Assay
K243396 · Hologic, 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
Xpert® Xpress CoV-2 plus
K230440 · Cepheid · Oct 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · Roche Molecular Systems, Inc. · Jun 2023