Cleared Traditional

Lyme-ID IgG Test; Bio-ID800

K252627 · Inanovate, Inc. · Microbiology

Nov 2025

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K252627 is an FDA 510(k) clearance for the Lyme-ID IgG Test; Bio-ID800, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Inanovate, Inc. (Sioux Falls, US). The FDA issued a Cleared decision on November 14, 2025, 86 days after receiving the submission on August 20, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number	K252627 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2025
Decision Date	November 14, 2025
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF