Cleared Traditional

K213804 - cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

K213804 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 320-day FDA review.

K213804 · Roche Molecular Systems, Inc. · Microbiology device
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Oct 2022
Decision
320d
Days
Class 2
Risk

K213804 is an FDA 510(k) clearance for the cobas SARS-CoV-2 Qualitative for use on the cobas 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 October 22, 2022 after a review of 320 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 - K213804

510(k) Number K213804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2021
Decision Date October 22, 2022
Days to Decision 320 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
218d slower than avg
Panel avg: 102d · This submission: 320d
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 K213804.
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