NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Microbiology · 21 CFR 866.3740 · Class 1
Overview
| Product Code | NJR |
|---|---|
| Device Name | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Cepheid | Sep 27, 2023 | SESE |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | May 9, 2022 | SESE |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Diasorin Molecular, LLC | Nov 7, 2018 | SESE |
| K181156 | Panther Fusion GBS Assay | Diagenode | Jul 27, 2018 | SESE |
| K173725 | NeuMoDx GBS Assay | Neumodx Molecular, Inc. | Jun 26, 2018 | SESE |
| K173250 | Solana GBS Assay | Quidel Corporation | Dec 21, 2017 | SESE |
| K170557 | GenePOC GBS LB | Genepoc, Inc. | May 25, 2017 | SESE |
| K162772 | ARIES GBS Assay | Luminex Corporation | Dec 23, 2016 | SESE |
| K143312 | Portrait GBS Assay | Great Basin Corporation | Apr 21, 2015 | SESE |
| K133503 | AMPLIVUE GBS ASSAY | Quidel Corporation | Dec 20, 2013 | SESE |
| K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) | Cepheid | Nov 2, 2012 | SESE |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | Meridian Bioscience, Inc. | May 1, 2012 | SESE |
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT | Becton, Dickinson & CO | Feb 16, 2012 | SESE |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | Meridian Bioscience, Inc. | Dec 5, 2011 | SESE |
| K090191 | HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB | Handylab, Inc. | May 27, 2010 | SESE |
| K062948 | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B | Cepheid | Dec 8, 2006 | SESE |
| K060540 | XPERT, GENEXPERT DX SYSTEM | Cepheid | Jul 25, 2006 | SESE |
| K022504 | IDI-STREP B ASSAY | Infectio Diagnostic, Inc. | Nov 18, 2002 | SESE |
Top Applicants
- Cepheid — 5 clearances
- Meridian Bioscience, Inc. — 2 clearances
- Quidel Corporation — 2 clearances
- Becton, Dickinson & CO — 1 clearance
- Diagenode — 1 clearance
