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510(k) K240867

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems by Roche Molecular Systems, Inc. — Product Code QQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2025
Date Received
March 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Device Class
Class II
Regulation Number
866.3981
Review Panel
MI
Submission Type

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.

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  • K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (July 31, 2025)
  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)
  • K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (April 25, 2025)
  • K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test (April 11, 2025)
  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)
  • K240197 — cobas® liat CT/NG/MG nucleic acid test (January 16, 2025)

Other clearances for product code QQX

  • K243396 — Aptima SARS-CoV-2 Assay (February 13, 2025)
  • K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (January 15, 2025)
  • K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 (December 6, 2024)
  • K233453 — Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (July 10, 2024)
  • K230440 — Xpert® Xpress CoV-2 plus (October 13, 2023)
  • K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (June 1, 2023)
  • K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (October 22, 2022)
  • K212147 — Simplexa COVID-19 Direct (September 13, 2022)
  • K221460 — BioFire COVID-19 Test 2 (July 25, 2022)
  • K211079 — BioFire COVID-19 Test 2 (November 1, 2021)