Cleared Traditional

K254295 - Sofia Lyme FIA

Also marketed or referenced as:
Sofia 2 Campylobacter FIA

K254295 is the FDA 510(k) clearance for Sofia Lyme FIA by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K254295 · Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
191d
Days
Class 2
Risk

K254295 is an FDA 510(k) clearance for the Sofia Lyme FIA. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) (San Diego, US). The FDA issued a Cleared decision on July 10, 2026 after a review of 191 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) devices

Submission Details

510(k) Number K254295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date July 10, 2026
Days to Decision 191 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 102d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LSR Reagent, Borrelia Serological Reagent

All 51
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