Cleared Traditional

Sentosa SA201 HSV 1/2 Qualitative PCR Test

K172509 · Vela Diagnostics USA, Inc. · Microbiology

Feb 2018

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K172509 is an FDA 510(k) clearance for the Sentosa SA201 HSV 1/2 Qualitative PCR Test, a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO), submitted by Vela Diagnostics USA, Inc. (Fairfield, US). The FDA issued a Cleared decision on February 1, 2018, 164 days after receiving the submission on August 21, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K172509 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2017
Decision Date	February 01, 2018
Days to Decision	164 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.