Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
The Nucleic Acid Amplification Assay System for Group B Streptococcus (Direct Specimen Test) is a microbiology diagnostic device including probes, reagents, and instrumentation intended to aid in the identification of Group B Streptococci (GBS) from specimens of pre-partum and intra-partum women to establish colonization status and guide prophylaxis decisions. It is classified as FDA Class 1 (General Controls), under product code NJR and regulation 21 CFR 866.3740 in the Microbiology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NJR
- Device Class
- FDA class 1
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Sep 27, 2023 | Substantially Equivalent | Cepheid |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | May 09, 2022 | Substantially Equivalent | Cepheid |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Nov 07, 2018 | Substantially Equivalent | Diasorin Molecular, LLC |
| K181156 | Panther Fusion GBS Assay | Jul 27, 2018 | Substantially Equivalent | Diagenode |
| K173725 | NeuMoDx GBS Assay | Jun 26, 2018 | Substantially Equivalent | Neumodx Molecular, Inc. |
| K173250 | Solana GBS Assay | Dec 21, 2017 | Substantially Equivalent | Quidel Corporation |
| K170557 | GenePOC GBS LB | May 25, 2017 | Substantially Equivalent | Genepoc, Inc. |
| K162772 | ARIES GBS Assay | Dec 23, 2016 | Substantially Equivalent | Luminex Corporation |
| K143312 | Portrait GBS Assay | Apr 21, 2015 | Substantially Equivalent | Great Basin Corporation |
| K133503 | AMPLIVUE GBS ASSAY | Dec 20, 2013 | Substantially Equivalent | Quidel Corporation |
| K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) | Nov 02, 2012 | Substantially Equivalent | Cepheid |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | May 01, 2012 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT | Feb 16, 2012 | Substantially Equivalent | Becton, Dickinson & CO |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | Dec 05, 2011 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K090191 | HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB | May 27, 2010 | Substantially Equivalent | Handylab, Inc. |
| K062948 | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B | Dec 08, 2006 | Substantially Equivalent | Cepheid |
| K060540 | XPERT, GENEXPERT DX SYSTEM | Jul 25, 2006 | Substantially Equivalent | Cepheid |
| K022504 | IDI-STREP B ASSAY | Nov 18, 2002 | Substantially Equivalent | Infectio Diagnostic, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.