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) → DGC — Ige, Antigen, Antiserum, Control # DGC · Ige, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5510 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC ## Overview - **Product Code:** DGC - **Device Name:** Ige, Antigen, Antiserum, Control - **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 114) Showing 20 most recent of 114 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231151](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K231151.md) | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | May 31, 2024 | SESE | | [K214068](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K214068.md) | Quantia IgE | Biokit, S.A. | Feb 21, 2023 | SESE | | [K220178](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K220178.md) | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | Mar 23, 2022 | SESE | | [K193493](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K193493.md) | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | Jan 15, 2020 | SESE | | [K161899](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K161899.md) | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | Phadia AB | Jul 28, 2016 | SESE | | [K133404](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K133404.md) | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | Phadia AB | Feb 24, 2014 | SESE | | [K063425](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K063425.md) | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | Feb 15, 2007 | SESE | | [K050493](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K050493.md) | QUANTIA IGE | Biokit, S.A. | Aug 16, 2005 | SESE | | [K042241](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K042241.md) | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Kamiya Biomedical Co. | Dec 10, 2004 | SESE | | [K034057](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K034057.md) | LACRYTEST | Adiatec SA | Mar 9, 2004 | SESE | | [K032251](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K032251.md) | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | Dec 19, 2003 | SESE | | [K024210](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K024210.md) | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | Beckman Coulter, Inc. | Feb 24, 2003 | SESE | | [K010855](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K010855.md) | RANDOX IGE | Randox Laboratories, Ltd. | May 15, 2001 | SESE | | [K002560](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K002560.md) | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | Oct 26, 2000 | SESE | | [K992528](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K992528.md) | BIOCHECK IGE ELISA, MODEL BC-1035 | Biocheck, Inc. | Sep 21, 1999 | SESE | | [K991316](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K991316.md) | TOUCH TEAR IGE MICROASSAY KIT | Touch Scientific, Inc. | Aug 9, 1999 | SESE | | [K991945](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K991945.md) | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Pharmacia & Upjohn Co. | Jul 28, 1999 | SESE | | [K991787](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K991787.md) | N LATEX IGE MONO REAGENT | Dade Behring, Inc. | Jul 7, 1999 | SESE | | [K983185](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K983185.md) | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Boehringer Mannheim Corp. | Nov 12, 1998 | SESE | | [K972697](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K972697.md) | AIA-PACK IGE II ASSAY | Tosoh Medics, Inc. | Oct 3, 1997 | SESE | ## Top Applicants - Pharmacia, Inc. — 16 clearances - Ventrex Laboratories, Inc. — 12 clearances - Kallestad Laboratories, Inc. — 8 clearances - Diagnostic Products Corp. — 6 clearances - Hybritech, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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