NJR · Class I · 21 CFR 866.3740

FDA Product Code NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

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.

Leading manufacturers include Cepheid, Meridian Bioscience, Inc. and Quidel Corporation.

18
Total
18
Cleared
171d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Devices (Product Code NJR)

18 devices
1–18 of 18
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638
Cepheid
Microbiology · 391d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429
Cepheid
Microbiology · 535d
Cleared Nov 07, 2018
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
K182467
Diasorin Molecular, LLC
Microbiology · 58d
Cleared Jul 27, 2018
Panther Fusion GBS Assay
K181156
Diagenode
Microbiology · 87d
Cleared Jun 26, 2018
NeuMoDx GBS Assay
K173725
Neumodx Molecular, Inc.
Microbiology · 203d
Cleared Dec 21, 2017
Solana GBS Assay
K173250
Quidel Corporation
Microbiology · 72d
Cleared May 25, 2017
GenePOC GBS LB
K170557
Genepoc, Inc.
Microbiology · 90d
Cleared Dec 23, 2016
ARIES GBS Assay
K162772
Luminex Corporation
Microbiology · 81d
Cleared Apr 21, 2015
Portrait GBS Assay
K143312
Great Basin Corporation
Microbiology · 154d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503
Quidel Corporation
Microbiology · 36d
Cleared Nov 02, 2012
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
K121539
Cepheid
Microbiology · 162d
Cleared May 01, 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Feb 16, 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860
Becton, Dickinson & CO
Microbiology · 231d
Cleared Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125
Meridian Bioscience, Inc.
Microbiology · 133d
Cleared May 27, 2010
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
K090191
Handylab, Inc.
Microbiology · 485d
Cleared Dec 08, 2006
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
K062948
Cepheid
Microbiology · 71d
Cleared Jul 25, 2006
XPERT, GENEXPERT DX SYSTEM
K060540
Cepheid
Microbiology · 146d

About Product Code NJR - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code NJR since 2002, with 18 receiving FDA clearance (average review time: 171 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.