Cleared Traditional

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

K150962 · Focus Diagnostics · Microbiology

Aug 2015

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K150962 is an FDA 510(k) clearance for the Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack, a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO), submitted by Focus Diagnostics (Cypress, US). The FDA issued a Cleared decision on August 28, 2015, 140 days after receiving the submission on April 10, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K150962 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2015
Decision Date	August 28, 2015
Days to Decision	140 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.