Cleared Special

K231306 - cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

K231306 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 Special 510(k) pathway after a 27-day FDA review.

K231306 · Roche Molecular Systems, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
27d
Days
Class 2
Risk

K231306 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 June 1, 2023 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - 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 - K231306

510(k) Number K231306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2023
Decision Date June 01, 2023
Days to Decision 27 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
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K231306.
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · Abbott Molecular · Dec 2024
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Simplexa COVID-19 Direct
K212147 · Diasorin Molecular, LLC · Sep 2022
BioFire COVID-19 Test 2
K221460 · Biofire Defense, LLC · Jul 2022
K231306 · cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
Download PDF FDA Summary Roche Molecular Syste…