Cleared Traditional

Elecsys HSV-1 IgG (08948844160)

K220923 · Roche Diagnostics · Microbiology

Oct 2022

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K220923 is an FDA 510(k) clearance for the Elecsys HSV-1 IgG (08948844160), a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on October 12, 2022, 195 days after receiving the submission on March 31, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K220923 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2022
Decision Date	October 12, 2022
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305