Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Q: What is the product code of K254295?

The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.

FDA 510(k) K254295 · Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Substantially Equivalent

510(k) numberK254295

Submission

Device name: Sofia Lyme FIA; Sofia 2 Campylobacter FIA
Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
San Diego, CA, US
Received: December 31, 2025
Decision date: July 10, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LSR – Reagent, Borrelia Serological Reagent
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3830
Specialty: Microbiology

Other 510(k)s with product code LSR

510(k)	Device	Applicant	Decision
K252627	Lyme-ID IgG Test; Bio-ID800LSR · Traditional	Inanovate, Inc.	11/14/2025SE
K242872	iDart Lyme IgM ImmunoBlot KitLSR · Traditional	Id-Fish Technology, Inc.	06/12/2025SE
K233367	iDart Lyme IgG ImmunoBlot KitLSR · Traditional	Id-Fish Technology, Inc.	08/12/2024SE
K230863	ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional	Zeus Scientific	07/13/2023SE
K220016	Viramed Borrela All-In-One ViraChip Test KitLSR · Traditional	Viramed Biotech AG	08/19/2022SE
K203296	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional	Gold Standard Diagnostics	03/22/2021SE
K203295	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional	Gold Standard Diagnostics	03/22/2021SE
K203292	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional	Gold Standard Diagnostics	03/22/2021SE
K203289	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional	Gold Standard Diagnostics	03/22/2021SE
K202574	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional	DiaSorin, Inc.	02/18/2021SE

More from DiaSorin, Inc.

510(k)	Device	Decision
K254264	Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track	09/04/2026SE
K254262	Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ · Dual Track	09/04/2026SE

Questions and answers

When was Sofia Lyme FIA; Sofia 2 Campylobacter FIA cleared by the FDA?

Sofia Lyme FIA; Sofia 2 Campylobacter FIA (K254295) received a 510(k) decision of Substantially Equivalent on July 10, 2026, 191 days after the submission was received.

What is the product code of K254295?

The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.