Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
FDA product code NJR · Class I (low risk) · 21 CFR 866.3740 · 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.
18510(k) clearances
0PMA approvals
11recalls
Manufacturers
510(k) clearances
| 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 |
| K181156 | Panther Fusion GBS AssayNJR · Traditional | Diagenode | 07/27/2018SE |
| 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 |
| K121044 | Illumigene Group B Streptococcus Carrot Broth ClaimNJR · Traditional | Meridian Bioscience, Inc. | 05/01/2012SE |
| K111860 | BD Max GBS Assay, BD Max InstrumentNJR · Traditional | Becton, Dickinson & CO | 02/16/2012SE |
| K112125 | Illumigene Group B Streptococcus ,External Control KitNJR · Traditional | Meridian Bioscience, Inc. | 12/05/2011SE |
| K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab DNA Extraction Strip, Handylab…NJR · Traditional | Handylab, Inc. | 05/27/2010SE |
| K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7BNJR · Traditional | Cepheid | 12/08/2006SE |
| K060540 | Xpert, Genexpert DX SystemNJR · Traditional | Cepheid | 07/25/2006SE |
| K022504 | Idi-Strep B AssayNJR · Traditional | Infectio Diagnostic, Inc. | 11/18/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0569-2026 Class II | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid…The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for… | Meridian Bioscience Inc | 10/07/2025Open, Classified |
| Z-1004-2025 Class II | BD PCR Cartridges used with MAX System. Model Number: 437519Potential for signal drift in specific lots of BD PCR Cartridges. | Becton Dickinson & Co. | 12/19/2024Open, Classified |
| Z-0907-2025 Class II | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent…Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect… | Hologic, Inc. | 12/13/2024Open, Classified |
| Z-0877-2022 Class II | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro…Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may… | Hologic, Inc | 03/18/2022Open, Classified |
| Z-2285-2019 Class II | ARIES GBS Assay , REF 50-10021, UDI # 00840487100165Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | Luminex Corporation | 02/20/2019Open, Classified |
| Z-0556-2016 Class II | Granada Biphasic Broth The product is a selective medium for the screening and…FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the… | Biomerieux Inc | 11/23/2015Terminated |
| Z-1662-2013 Class III | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction…Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards… | Becton Dickinson & Co. | 05/31/2013Terminated |
| Z-0976-2013 Class II | BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX…Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or… | Becton Dickinson & Co. | 12/11/2012Terminated |
| Z-0701-2013 Class II | Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number…Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. | Becton Dickinson & Co. | 09/18/2012Terminated |
| Z-2401-2011 | Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for…A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results… | Cepheid | 04/01/2011Terminated |
| Z-0376-2008 | Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for…Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information… | Cepheid | 09/05/2007Terminated |