FDA 510(k) clearance · back to tracker

Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) cleared K254295 on 2026-07-10, decision: substantially equivalent

K-number

K254295

Sponsor

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Device

Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-10

Product code

LSR

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3830

Official FDA record

Open K254295on 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.

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Drop K254295 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.