Method, Nephelometric, Immunoglobulins (G, A, M)
FDA product code CFN · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
61510(k) clearances
0PMA approvals
18recalls
Manufacturers
- The Binding Site, Ltd. 15
- The Binding Site Group , Ltd. 14
- Dade Behring, Inc. 6
- Beckman Coulter Inc. 4
- Antibodies, Inc. 3
- Olympus America, Inc. 3
- Crestat Diagnostics, Inc. 3
- Wako Chemicals USA, Inc. 2
- Behring Diagnostics, Inc. 2
- Siemens Healthcare Diagnostics, Inc. 2
- Roche Diagnostic Systems, Inc. 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Eiken Chemical Co., Ltd. 1
- Ortho-Clinical Diagnostics 1
- Hyland Therapeutic Div., Travenol Laboratories 1
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 1
- Siemens Healthcare Diagnostics Products GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)CFN · Special | Siemens Healthcare Diagnostics Products GmbH | 12/13/2023SE |
| K221114 | Immunoglobulin G (IgG)CFN · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 08/02/2023SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | The Binding Site Group , Ltd. | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | The Binding Site Group , Ltd. | 07/15/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 01/23/2019SE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentCFN · Traditional | Beckman Coulter, Inc. | 01/09/2017SE |
| K150526 | Optilite IgG4 KitCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2015SE |
| K142735 | The Optilite IgG3 kitCFN · Traditional | The Binding Site Group , Ltd. | 12/21/2014SE |
| K130122 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman…CFN · Traditional | Beckman Coulter, Inc. | 01/07/2014SE |
| K120901 | Human Iga CSF Kit for Use on SpaplusCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2013SE |
| K120750 | Human Igm CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/17/2013SE |
| K120749 | Human Igg CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/17/2013SE |
| K113823 | Hevylite Human Igm Kappa and Hevylite Igm Lambda KitCFN · Traditional | The Binding Site Group , Ltd. | 03/27/2013SE |
| K103824 | Human Iga Liquid Reagent Kit for Use on SPA PlusCFN · Traditional | The Binding Site | 02/27/2012SE |
| K100588 | Human IGA2 Kit for Use on the SpaplusCFN · Traditional | The Binding Site Group , Ltd. | 08/16/2010SE |
| K082823 | Hevylite Human Iga Kappa and Iga Lambda BN KitsCFN · Traditional | The Binding Site Group , Ltd. | 03/01/2010SE |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)CFN · Traditional | The Binding Site, Ltd. | 12/30/2009SE |
| K090594 | Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista…CFN · Traditional | Siemens Healthcare Diagnostics | 04/29/2009SE |
| K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCCFN · Traditional | Siemens Healthcare Diagnostics | 03/24/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | The Binding Site, Ltd. | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | The Binding Site, Ltd. | 12/19/2008SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | Dade Behring, Inc. | 07/28/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | Dade Behring, Inc. | 02/26/2008SE |
| K073490 | Olympus Igg ReagentCFN · Traditional | Olympus America, Inc. | 02/11/2008SE |
| K073489 | Olympus Iga ReagentCFN · Traditional | Olympus America, Inc. | 02/11/2008SE |
| K073487 | Olympus Igm ReagentCFN · Traditional | Olympus America, Inc. | 02/11/2008SE |
| K072889 | Human Igg Subclass Liquid Reagent Kits for Use on the Spaplus AnalyserCFN · Traditional | The Binding Site, Ltd. | 02/01/2008SE |
| K061845 | Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and HCFN · Traditional | Dade Behring, Inc. | 08/24/2006SE |
| K061338 | Dimension Vista Iga Flex Reagent Cartridge AssayCFN · Traditional | Dade Behring, Inc. | 07/06/2006SE |
| K042735 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm)CFN · Traditional | Dade Behring, Inc. | 02/15/2005SE |
| K042152 | Binding Site Igg Sublcass Olympus KitsCFN · Traditional | The Binding Site | 11/22/2004SE |
| K042475 | Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator…CFN · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/10/2004SE |
| K032014 | N Latex IgmCFN · Traditional | Dade Behring, Inc. | 08/07/2003SE |
| K022083 | Human Igg Subclass Kit for Use on the Beckman Immage AnalyserCFN · Traditional | The Binding Site, Ltd. | 07/16/2002SE |
| K012296 | Human Igg Subclass Liquid Reagent Kits, Product Code LK001.TCFN · Traditional | The Binding Site, Ltd. | 08/31/2001SE |
| K012292 | Human Igg Subclass Liquid Reagent Kits, Product Code LK001.TBCFN · Traditional | The Binding Site, Ltd. | 08/31/2001SE |
| K012295 | Human Igg Subclass Liquid Reagent Kits, Product Code NK001.TCFN · Traditional | The Binding Site, Ltd. | 08/20/2001SE |
| K012291 | Human Igg Subclass Liquid Reagent Kits, Product Code LK001.TACFN · Traditional | The Binding Site, Ltd. | 08/20/2001SE |
| K000701 | Human Igg Subclass Kit Use with the Beckman Image AnalyzerCFN · Traditional | The Binding Site, Ltd. | 04/27/2000SE |
| K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…CFN · Traditional | Beckman Coulter, Inc. | 02/01/2000SE |
| K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…CFN · Traditional | Beckman Coulter, Inc. | 02/01/2000SE |
| K993924 | Wako Igm Ii- Ha, Immunolobulin Calibrator Set, Immunolobulin StandardCFN · Traditional | Wako Chemicals USA, Inc. | 01/14/2000SE |
| K981784 | Igm Minineph AntiserumCFN · Traditional | The Binding Site, Ltd. | 12/21/1999SE |
| K982100 | Igg and Igg Subclass Nephelometric Diagnostic Test KitsCFN · Traditional | The Binding Site, Ltd. | 12/20/1999SE |
| K981912 | Human Iga Subclass Bnii Combi KitCFN · Traditional | The Binding Site, Ltd. | 12/04/1998SE |
| K982382 | Cobas Integra Reagent CassettesCFN · Traditional | Roche Diagnostic Systems, Inc. | 09/28/1998SE |
| K933971 | N-Assay Tia IgaCFN · Traditional | Crestat Diagnostics, Inc. | 03/22/1994SE |
| K933970 | N-Assay Tia IgmCFN · Traditional | Crestat Diagnostics, Inc. | 03/22/1994SE |
| K933973 | N-Assay Tia Multi V-NlCFN · Traditional | Crestat Diagnostics, Inc. | 01/28/1994SE |
| K923070 | Wako Igg-HaCFN · Traditional | Wako Chemicals USA, Inc. | 08/20/1992SE |
| K880356 | N Protein Standard Plasma (Human)CFN · Traditional | Behring Diagnostics, Inc. | 04/07/1988SE |
| K871343 | QM2/QM300 Buffer and Diluent PackCFN · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 05/15/1987SE |
| K864342 | Multipurpose Immunochemistry System LA-2000 LatexCFN · Traditional | Eiken Chemical Co., Inc. | 12/01/1986SE |
| K860894 | Behring Nephelometer SystemCFN · Traditional | Behring Diagnostics, Inc. | 04/15/1986SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | Antibodies, Inc. | 11/08/1978SE |
| K781655 | Nephelrate Antiserums 1GACFN · Traditional | Antibodies, Inc. | 11/08/1978SE |
| K781654 | Nephelrate Antiperums LGMCFN · Traditional | Antibodies, Inc. | 11/08/1978SE |
| K771226 | Las-R Test ProgramCFN · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 07/21/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2428-2024 Class II | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as… | Beckman Coulter Inc. | 05/27/2024Open, Classified |
| Z-1003-2024 Class II | Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryPotential for a negative bias with quality control (QC) and patient sample results when using the Atellica… | Siemens Healthcare Diagnostics, Inc. | 12/15/2023Open, Classified |
| Z-2488-2023 Class II | Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2Lipemic interference failed to meet the performance specification listed within the IFU. | Beckman Coulter Inc. | 07/12/2023Open, Classified |
| Z-0094-2023 Class II | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD…N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for… | Siemens Healthcare Diagnostics Inc | 08/30/2022Open, Classified |
| Z-0093-2023 Class II | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens…N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for… | Siemens Healthcare Diagnostics Inc | 08/30/2022Open, Classified |
| Z-1327-2020 Class II | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565There is a potential that users may experience difficulty validating the calibration of the kit. This is… | The Binding Site Group, Ltd. | 07/29/2019Terminated |
| Z-0604-2019 Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…Firm is offering advice to customers experiencing challenges when validating the calibration curve of the… | The Binding Site Group, Ltd. | 11/06/2018Terminated |
| Z-0477-2019 Class II | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a… | The Binding Site Group, Ltd. | 07/25/2018Terminated |
| Z-1089-2017 Class III | Optilite IgG4 Kit Product Code: LK009.OPT.AA change to the lower end of the measuring range and product insert did not reflect the change.The measuring… | The Binding Site Group, Ltd. | 12/23/2016Terminated |
| Z-1289-2015 Class III | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in…Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when… | Siemens Healthcare Diagnostics, Inc. | 01/15/2015Terminated |
| Z-1073-2017 Class II | MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-1072-2017 Class II | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-1071-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-1070-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-1069-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-1068-2017 Class II | Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-1067-2017 Class II | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | The Binding Site Group, Ltd. | 09/11/2014Terminated |
| Z-0356-2007 | Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in…Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay… | Roche Diagnostics Corp. | 12/15/2006Terminated |