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) → CFF — Immunoelectrophoretic, Immunoglobulins, (G, A, M) # CFF · Immunoelectrophoretic, 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/CFF ## Overview - **Product Code:** CFF - **Device Name:** Immunoelectrophoretic, 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 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K203184](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K203184.md) | HYDRASHIFT 2/4 isatuximab | Sebia | Nov 12, 2021 | SESE | | [K192095](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K192095.md) | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | Nov 1, 2019 | SESE | | [K190851](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K190851.md) | HYDRASHIFT 2/4 daratumumab | Sebia | May 2, 2019 | SESE | | [K172195](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K172195.md) | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Sebia | Jan 11, 2018 | SESE | | [K161928](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K161928.md) | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | Sebia | Dec 21, 2016 | SESE | | [K143483](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K143483.md) | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia | Jan 8, 2015 | SESE | | [K120169](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K120169.md) | INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT | Grifols USA, LLC | Aug 24, 2012 | SESE | | [K111369](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K111369.md) | THE HELENA V8 IMMUNODISPLACEMENT KIT | Helena Laboratories Uk, Ltd. | Jun 26, 2012 | SESE | | [K103757](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K103757.md) | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT | Grifols | Oct 13, 2011 | SESE | | [K082085](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K082085.md) | CAPILLARYS IMMUNOTYPING, MODEL 2100 | Sebia | Apr 17, 2009 | SESE | | [K082388](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K082388.md) | MINICAP IMMUNOTYPING, MODEL: 2300 | Sebia | Apr 14, 2009 | SESE | | [K061069](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K061069.md) | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | Helena Laboratories | Jul 6, 2006 | SESE | | [K033187](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033187.md) | INTERLAB IMMUNOFIXATION TEST(S) | Interlab S.R.L. | Nov 19, 2003 | SESE | | [K033277](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K033277.md) | HYDRAGEL CSF ISOFOCUSING KITS | Morax | Nov 4, 2003 | SESE | | [K024162](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K024162.md) | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Helena Laboratories | Feb 19, 2003 | SESE | | [K002799](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K002799.md) | PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 | Beckman Coulter, Inc. | Oct 5, 2000 | SESE | | [K993323](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K993323.md) | K-ASSAY IGM | Kamiya Biomedical Co. | Nov 30, 1999 | SESE | | [K993213](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K993213.md) | K-ASSAY IGA | Kamiya Biomedical Co. | Nov 23, 1999 | SESE | | [K990998](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K990998.md) | POLYSLIT IFE KIT | Helena Laboratories | Jun 28, 1999 | SESE | | [K981048](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K981048.md) | HYDRAGEL 6 CSF KIT | Morax | Oct 7, 1998 | SESE | ## Top Applicants - Sebia — 8 clearances - Helena Laboratories — 6 clearances - Morax — 3 clearances - Kamiya Biomedical Co. — 2 clearances - The Binding Site, Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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