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cobas BKV

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203220

by Roche Molecular Systems, Inc.

Identifiers

510(k) Number
K203220 FDA 510(k)
FDA Product Code
QLX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3183 FDA 510(k)
Regulation Number
866.3183 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The cobas BKV is a nucleic acid amplification test designed for the quantitation of BK virus (BKV) DNA. It falls under the category of a Nucleic Acid Amplification Test (NAAT) and is intended for detecting and measuring BKV DNA levels in clinical samples, aiding in the diagnosis and monitoring of BK virus infection.

This test is supplied for use on the automated cobas 5800, 6800, and 8800 Systems and is intended for in vitro use on human EDTA plasma and urine stabilized in cobas PCR Media. It is a single-use reagent kit and is regulated under FDA 510(k) clearance (K203220) as a Class II device (866.3183). The device is intended for microbiology applications and is not MRI-compatible.

Frequently asked questions

What clinical samples can the cobas BKV test analyze, and how should they be prepared before testing?

The cobas BKV test is designed to analyze human EDTA plasma and urine samples that have been stabilized in cobas PCR Media. This stabilization ensures sample integrity and compatibility with the automated cobas 5800, 6800, and 8800 Systems, which are required for processing the test.

Is the cobas BKV test reusable, or is it intended for single-use only?

The cobas BKV is supplied as a single-use reagent kit. Each kit is intended for one test run on the cobas 5800, 6800, or 8800 Systems, ensuring consistency and preventing cross-contamination between samples.

What systems does the cobas BKV test require for operation, and is it compatible with any other platforms?

The cobas BKV test is specifically designed for use on the automated Roche Molecular Systems cobas 5800, 6800, and 8800 Systems. It is not compatible with other platforms or manual testing methods, as it relies on these systems for nucleic acid amplification and quantitation.

How is the regulatory status of the cobas BKV test defined, and what does this mean for its use in clinical settings?

The cobas BKV test holds FDA 510(k) clearance (K203220) as a Class II device under product code QLX, categorized under microbiology applications. This clearance indicates it is considered substantially equivalent to a predicate device and is approved for in vitro diagnostic use in detecting and quantifying BK virus DNA in specified clinical samples.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cobas® BKV - Roche Diagnostics USA, cobas® BKV - Roche Diagnostics USA, K202215 FDA 510(k) - cobas BKV | Roche Molecular Systems, Inc., PDF September 2, 2020 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Molecular Systems, Inc.

Sources (1)

  • FDA 510(k) K203220 24 fields · synced Sep 19, 2026