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) → DEW — Igg, Antigen, Antiserum, Control # DEW · Igg, 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/DEW ## Overview - **Product Code:** DEW - **Device Name:** Igg, 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 76) Showing 20 most recent of 76 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K050113](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K050113.md) | TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | Feb 8, 2005 | SESE | | [K040434](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K040434.md) | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | Roche Diagnostics Corp. | Mar 10, 2004 | SESE | | [K010617](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K010617.md) | SPIFE IFE CALIBRATOR AND CONTROL KIT | Helena Laboratories | Mar 15, 2001 | SESE | | [K993928](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K993928.md) | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | Jan 18, 2000 | SESE | | [K993281](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K993281.md) | K-ASSAY IGG | Kamiya Biomedical Co. | Nov 9, 1999 | SESE | | [K983221](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K983221.md) | IGG | Abbott Laboratories | Nov 4, 1998 | SESE | | [K965108](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K965108.md) | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | Beckman Instruments, Inc. | Mar 6, 1997 | SESE | | [K963974](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K963974.md) | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | Beckman Instruments, Inc. | Mar 6, 1997 | SESE | | [K963868](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K963868.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | Beckman Instruments, Inc. | Feb 10, 1997 | SESE | | [K962202](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K962202.md) | QUANTEX IGG | Instrumentation Laboratory CO | Sep 26, 1996 | SESE | | [K955798](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K955798.md) | IGG IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | Apr 5, 1996 | SESE | | [K951635](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K951635.md) | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL | Beckman Instruments, Inc. | May 15, 1995 | SESE | | [K943997](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K943997.md) | BEHRING NEPHELOMETER II | Behring Diagnostics, Inc. | Oct 3, 1994 | SESE | | [K934324](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K934324.md) | OT IGG SORBENT | Organon Teknika Corp. | Apr 21, 1994 | SESE | | [K933314](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K933314.md) | RADIAS FERRITIN ENZYME IMMUNOASSAY | Bio-Rad | Sep 8, 1993 | SESE | | [K924197](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K924197.md) | ZORBA(TM) IGG REMOVAL REAGENT | Zeus Scientific, Inc. | Dec 15, 1992 | SESE | | [K921575](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K921575.md) | IGG SUCLASS EIA | Virotech Diagnostika | May 28, 1992 | SESE | | [K911610](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K911610.md) | ELISA COMBI-KIT HUMAN IGG SUBCLASSES | Janssen Research Foundation | Jun 12, 1991 | SESE | | [K900943](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K900943.md) | MODIFIED TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | Apr 26, 1990 | SESE | | [K893419](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW/K893419.md) | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Coulter Immunology | Aug 3, 1989 | SESE | ## Top Applicants - Kent Laboratories, Inc. — 5 clearances - Beckman Instruments, Inc. — 4 clearances - Dako Corp. — 4 clearances - Icl Scientific — 4 clearances - Abbott Laboratories — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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