FDA 510(k) clearance · back to tracker

cobas® BV/CV

Roche Molecular Systems, Inc. cleared K260021 on 2026-07-16, decision: substantially equivalent

K-number

K260021

Sponsor

Roche Molecular Systems, Inc.

Device

cobas® BV/CV

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-16

Product code

PQA

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3975

Official FDA record

Open K260021on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K260021 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.