Cleared Traditional

iDart Lyme IgM ImmunoBlot Kit

K242872 · Id-Fish Technology, Inc. · Microbiology
Jun 2025
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K242872 is an FDA 510(k) clearance for the iDart Lyme IgM ImmunoBlot Kit, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Id-Fish Technology, Inc. (Milpitas, US). The FDA issued a Cleared decision on June 12, 2025, 262 days after receiving the submission on September 23, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K242872 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2024
Decision Date June 12, 2025
Days to Decision 262 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

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