Cleared Traditional

Alinity m HSV 1 & 2 / VZV

K233349 · Abbott Molecular, Inc. · Microbiology

May 2024

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K233349 is an FDA 510(k) clearance for the Alinity m HSV 1 & 2 / VZV, a Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II — Special Controls, product code PGI), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 3, 2024, 217 days after receiving the submission on September 29, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3309.

Submission Details

510(k) Number	K233349 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2023
Decision Date	May 03, 2024
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PGI — Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3309
Definition	For The Qualitative Detection And Differentiation Of Vzv, Hsv1, Hsv2- Dna In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.