Cleared Traditional

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

K243575 · Biokit, S.A. · Microbiology

Feb 2025

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K243575 is an FDA 510(k) clearance for the ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II — Special Controls, product code MYF), submitted by Biokit, S.A. (Lli?? D?Amunt, Barcelona, ES). The FDA issued a Cleared decision on February 12, 2025, 85 days after receiving the submission on November 19, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K243575 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2024
Decision Date	February 12, 2025
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305