FDA 510(k) clearance · back to tracker

Elecsys EBV EBNA IgG

Roche Diagnostics cleared K260221 on 2026-10-02, decision: substantially equivalent

K-number

K260221

Sponsor

Roche Diagnostics

Device

Elecsys EBV EBNA IgG

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-10-02

Product code

LSE

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3235

Official FDA record

Open K260221on 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 K260221 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.

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Source

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