Panther Fusion GBS Assay

Q: What is the product code of K181156?

The FDA product code is NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a Class I (low risk) device regulated under 21 CFR 866.3740.

FDA 510(k) K181156 · Diagenode

Substantially Equivalent

510(k) numberK181156

Submission

Device name: Panther Fusion GBS Assay
Applicant: Diagenode
Seraing, BE
Received: May 1, 2018
Decision date: July 27, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device class: Class I (low risk)
Regulation: 21 CFR 866.3740
Specialty: Microbiology

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.

Other 510(k)s with product code NJR

510(k)	Device	Applicant	Decision
K222638	Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR · Traditional	Cepheid	09/27/2023SE
K203429	Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJR · Traditional	Cepheid	05/09/2022SE
K182467	Simplexa GBS Direct, Simplexa GBS Positive Control PackNJR · Traditional	Diasorin Molecular, LLC	11/07/2018SE
K173725	NeuMoDx GBS AssayNJR · Traditional	Neumodx Molecular, Inc.	06/26/2018SE
K173250	Solana GBS AssayNJR · Traditional	Quidel Corporation	12/21/2017SE
K170557	GenePOC GBS LBNJR · Traditional	Genepoc, Inc.	05/25/2017SE
K162772	ARIES GBS AssayNJR · Traditional	Luminex Corporation	12/23/2016SE
K143312	Portrait GBS AssayNJR · Traditional	Great Basin Corporation	04/21/2015SE
K133503	Amplivue GBS AssayNJR · Traditional	Quidel Corporation	12/20/2013SE
K121539	Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert…NJR · Traditional	Cepheid	11/02/2012SE

Questions and answers

When was Panther Fusion GBS Assay cleared by the FDA?

Panther Fusion GBS Assay (K181156) received a 510(k) decision of Substantially Equivalent on July 27, 2018, 87 days after the submission was received.

What is the product code of K181156?

The FDA product code is NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a Class I (low risk) device regulated under 21 CFR 866.3740.