Imdx HSV-1/2 for Abbott M2000

Q: What is the product code of K140198?

The FDA product code is OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3305.

FDA 510(k) K140198 · Intelligent Medical Devices, Inc.

Substantially Equivalent

510(k) numberK140198

Submission

Device name: Imdx HSV-1/2 for Abbott M2000
Applicant: Intelligent Medical Devices, Inc.
Beverly, MA, US
Received: January 27, 2014
Decision date: May 13, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3305
Specialty: Microbiology

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.

Other 510(k)s with product code OQO

510(k)	Device	Applicant	Decision
K172509	Sentosa SA201 HSV 1/2 Qualitative PCR TestOQO · Traditional	Vela Diagnostics USA, Inc.	02/01/2018SE
K162673	Aptima Herpes Simplex Viruses 1 & 2 AssayOQO · Traditional	Hologic, Inc.	06/15/2017SE
K150962	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO · Traditional	Focus Diagnostics	08/28/2015SE
K150617	cobas HSV 1 and 2 TestOQO · Traditional	Roche Molecular Systems, Inc.	06/01/2015SE
K142156	Seegene Anyplex II HSV-1/2 AssayOQO · Traditional	Seegene	02/13/2015SE
K142738	artus HSV-1/2 QS-RGQ MDx KitOQO · Traditional	Qiagen	12/19/2014SE
K140029	Amiplivue HSV 1&2 AssayOQO · Traditional	Quidel Corporation	03/26/2014SE
K111951	Isoamp HSV AssayOQO · Traditional	Biohelix Corporation	09/27/2011SE
K111527	Multicode-Rtx Herpes Simplex Virus 1 & 2 KitOQO · Traditional	Eragen Biosciences, Inc.	08/03/2011SE
K103798	BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA AssaysOQO · Traditional	Becton, Dickinson & CO	03/18/2011SE

More from Becton, Dickinson & CO

510(k)	Device	Decision
K132235	Imdx C.Difficile for Abbott M2000OZN · Traditional	10/11/2013SE
K131584	Imdx Flu A/B and RSV for Abbott M2000OCC · Traditional	08/21/2013SE
K123753	Imdx Vanr for Abbott M2000NIJ · Traditional	07/17/2013SE

Questions and answers

When was Imdx HSV-1/2 for Abbott M2000 cleared by the FDA?

Imdx HSV-1/2 for Abbott M2000 (K140198) received a 510(k) decision of Substantially Equivalent on May 13, 2014, 106 days after the submission was received.

What is the product code of K140198?

The FDA product code is OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3305.