510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231306Substantially Equivalent

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

Roche Molecular Systems Inc, Pleasanton CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231306 is the FDA 510(k) clearance record for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test). FDA's definition for product code QQX reads: "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...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show no recalls naming K231306.

Clearance record

Decision date
Received
(27 days to decision)
Product code
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Regulation
21 CFR 866.3981
Device class
Class II
Review panel
Microbiology
Applicant
Roche Molecular Systems, Inc. 4300 Hacienda Dr., Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQX

Trailing 12 months

FDA records hold no clearances under product code QQX in the trailing twelve months.

FDA records show no clearances under product code QQX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260