Cleared Traditional

K162673 - Aptima Herpes Simplex Viruses 1 & 2 Assay
(FDA 510(k) Clearance)

K162673 · Hologic, Inc. · Microbiology

Jun 2017

Decision

262d

Days

Class 2

Risk

K162673 is an FDA 510(k) clearance for the Aptima Herpes Simplex Viruses 1 & 2 Assay. This device is classified as a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO).

Submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on June 15, 2017, 262 days after receiving the submission on September 26, 2016.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305. A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens..

Submission Details

510(k) Number	K162673 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2016
Decision Date	June 15, 2017
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305
Definition	A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens.