Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → CFN — Method, Nephelometric, Immunoglobulins (G, A, M) # CFN · Method, Nephelometric, Immunoglobulins (G, A, M) _Immunology · 21 CFR 866.5510 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN ## Overview - **Product Code:** CFN - **Device Name:** Method, Nephelometric, Immunoglobulins (G, A, M) - **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233663](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K233663.md) | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | Dec 13, 2023 | SESE | | [K221114](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K221114.md) | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Aug 2, 2023 | SESE | | [K192116](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K192116.md) | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | Sep 4, 2019 | SESE | | [K191985](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K191985.md) | Optilite IgA Kit | The Binding Site Group , Ltd. | Aug 19, 2019 | SESE | | [K191635](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K191635.md) | Optilite IgM Kit | The Binding Site Group , Ltd. | Jul 15, 2019 | SESE | | [K191465](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K191465.md) | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | Jun 27, 2019 | SESE | | [K190686](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K190686.md) | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | May 28, 2019 | SESE | | [K183151](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K183151.md) | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | Jan 23, 2019 | SESE | | [K162208](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K162208.md) | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | Jan 9, 2017 | SESE | | [K150526](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K150526.md) | Optilite IgG4 Kit | The Binding Site Group , Ltd. | May 30, 2015 | SESE | | [K142735](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K142735.md) | The Optilite IgG3 kit | The Binding Site Group , Ltd. | Dec 21, 2014 | SESE | | [K130122](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K130122.md) | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | Beckman Coulter, Inc. | Jan 7, 2014 | SESE | | [K120901](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K120901.md) | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | May 30, 2013 | SESE | | [K120750](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K120750.md) | HUMAN IGM CSF KIT | The Binding Site Group , Ltd. | May 17, 2013 | SESE | | [K120749](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K120749.md) | HUMAN IGG CSF KIT | The Binding Site Group , Ltd. | May 17, 2013 | SESE | | [K113823](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K113823.md) | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | Mar 27, 2013 | SESE | | [K103824](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K103824.md) | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | The Binding Site | Feb 27, 2012 | SESE | | [K100588](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K100588.md) | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | Aug 16, 2010 | SESE | | [K082823](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K082823.md) | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | The Binding Site Group , Ltd. | Mar 1, 2010 | SESE | | [K090920](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN/K090920.md) | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | The Binding Site, Ltd. | Dec 30, 2009 | SESE | ## Top Applicants - The Binding Site Group , Ltd. — 14 clearances - The Binding Site, Ltd. — 13 clearances - Dade Behring, Inc. — 6 clearances - Beckman Coulter, Inc. — 4 clearances - Antibodies, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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