Cleared Traditional

Anti-Borrelia burgdorferi US Westernblot (IgG)

K161513 · Euroimmun US · Microbiology
Aug 2016
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K161513 is an FDA 510(k) clearance for the Anti-Borrelia burgdorferi US Westernblot (IgG), a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on August 25, 2016, 84 days after receiving the submission on June 2, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K161513 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2016
Decision Date August 25, 2016
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

Similar Devices — LSR Reagent, Borrelia Serological Reagent

All 110
Lyme-ID IgG Test; Bio-ID800
K252627 · Inanovate, Inc. · Nov 2025
iDart Lyme IgM ImmunoBlot Kit
K242872 · Id-Fish Technology, Inc. · Jun 2025
iDart Lyme IgG ImmunoBlot Kit
K233367 · Id-Fish Technology, Inc. · Aug 2024
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
K230863 · Zeus Scientific · Jul 2023
Viramed Borrela All-In-One ViraChip Test Kit
K220016 · Viramed Biotech AG · Aug 2022
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · Gold Standard Diagnostics · Mar 2021