Cleared Traditional

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS

K103798 · Becton, Dickinson & CO · Microbiology

Mar 2011

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K103798 is an FDA 510(k) clearance for the BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS, a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on March 18, 2011, 81 days after receiving the submission on December 27, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K103798 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2010
Decision Date	March 18, 2011
Days to Decision	81 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.