510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202215Substantially Equivalent

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

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

K202215 is the FDA 510(k) clearance record for cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code QMI (Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna). FDA's definition for product code QMI reads: "An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show no recalls naming K202215.

Clearance record

Decision date
Received
(27 days to decision)
Product code
QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Regulation
21 CFR 866.3183
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 QMI

Trailing 12 months

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

FDA records show no clearances under product code QMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMI, 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