Cleared Traditional

IMDX HSV-1/2 FOR ABBOTT M2000

K140198 · Intelligent Medical Devices, Inc. · Microbiology

May 2014

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K140198 is an FDA 510(k) clearance for the IMDX HSV-1/2 FOR ABBOTT M2000, a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO), submitted by Intelligent Medical Devices, Inc. (Beverly, US). The FDA issued a Cleared decision on May 13, 2014, 106 days after receiving the submission on January 27, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K140198 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2014
Decision Date	May 13, 2014
Days to Decision	106 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.