cobas BKV

Q: When was cobas BKV cleared by the FDA?

cobas BKV (K203220) received a 510(k) decision of Substantially Equivalent on January 29, 2021, 88 days after the submission was received.

Q: What is the product code of K203220?

The FDA product code is QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna, a Class II (moderate risk) device regulated under 21 CFR 866.3183.

FDA 510(k) K203220 · Roche Molecular Systems, Inc.

Substantially Equivalent

510(k) numberK203220

Submission

Device name: cobas BKV
Applicant: Roche Molecular Systems, Inc.
Pleasanton, CA, US
Received: November 2, 2020
Decision date: January 29, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3183
Specialty: Microbiology

A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant…

Other 510(k)s with product code QLX

510(k)	Device	Applicant	Decision
K243489	Alinity m EBV (09N43-095)QLX · Traditional	Abbott Molecular, Inc.	07/28/2025SE
K212778	Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…QLX · Traditional	Abbott Molecular, Inc.	07/15/2022SE

More from Abbott Molecular, Inc.

510(k)	Device	Decision
K260047	cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional	08/28/2026SE
K260045	cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional	08/28/2026SE
K260021	cobas® BV/CVPQA · Traditional	07/16/2026SE
K260917	cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional	07/08/2026SE
K253759	cobas liat CT/NG/MG nucleic acid testQEP · Dual Track	05/15/2026SE
K253756	cobas liat CT/NG nucleic acid testQEP · Dual Track	05/15/2026SE
K243753	cobas liat Bordetella panel nucleic acid testOZZ · Dual Track	11/20/2025SE
K252484	cobas HCVMZP · Traditional	11/03/2025SE
K252481	cobas CMVPAB · Traditional	11/03/2025SE
K243455	cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional	07/31/2025SE

Questions and answers

When was cobas BKV cleared by the FDA?

cobas BKV (K203220) received a 510(k) decision of Substantially Equivalent on January 29, 2021, 88 days after the submission was received.

What is the product code of K203220?

The FDA product code is QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna, a Class II (moderate risk) device regulated under 21 CFR 866.3183.