Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5630](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5630) → JZG — System, Test, Beta-2-Microglobulin Immunological # JZG · System, Test, Beta-2-Microglobulin Immunological _Immunology · 21 CFR 866.5630 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG ## Overview - **Product Code:** JZG - **Device Name:** System, Test, Beta-2-Microglobulin Immunological - **Regulation:** [21 CFR 866.5630](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5630) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) ## Identification A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Recent Cleared Devices (20 of 53) Showing 20 most recent of 53 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K161297](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K161297.md) | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | Jun 7, 2016 | SESE | | [K122066](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K122066.md) | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | Aug 30, 2012 | SESE | | [K110874](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K110874.md) | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Jan 20, 2012 | SESE | | [K083289](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K083289.md) | HUMAN BETA-2 MICROGLOBULIN KIT | The Binding Site, Ltd. | May 6, 2009 | SESE | | [K083463](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K083463.md) | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | Siemens Healthcare Diagnostics | Mar 13, 2009 | SESE | | [K072078](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K072078.md) | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | Dec 19, 2007 | SESE | | [K063272](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K063272.md) | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH | Dade Behring, Inc. | Jan 26, 2007 | SESE | | [K050613](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K050613.md) | QUANTIA BETA-2 MICROGLOBULIN | Biokit, S.A. | Aug 16, 2005 | SESE | | [K032692](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K032692.md) | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | Dako A/S | Jan 22, 2004 | SESE | | [K014270](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K014270.md) | MININEPH HUMAN B2-MICROGLOBULIN KIT | The Binding Site, Ltd. | Aug 15, 2002 | SESE | | [K002731](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K002731.md) | N LATEX B2-MICROGLOBULIN | Dade Behring, Inc. | Nov 20, 2000 | SESE | | [K001022](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K001022.md) | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | Biocheck, Inc. | Sep 26, 2000 | SESE | | [K993711](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K993711.md) | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | Bayer Corp. | Dec 16, 1999 | SESE | | [K991136](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K991136.md) | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | Olympus America, Inc. | May 11, 1999 | SESE | | [K983895](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K983895.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | Beckman Coulter, Inc. | Nov 25, 1998 | SESE | | [K980724](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K980724.md) | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | Oct 16, 1998 | SESE | | [K973813](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K973813.md) | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | Beckman Instruments, Inc. | Nov 20, 1997 | SESE | | [K964791](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K964791.md) | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | May 29, 1997 | SESE | | [K964767](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K964767.md) | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | R&D Systems, Inc. | May 29, 1997 | SESE | | [K955596](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K955596.md) | N LATEX B2-MICROGLOBULIN REAGENT | Behring Diagnostics, Inc. | Oct 3, 1996 | SESE | ## Top Applicants - The Binding Site, Ltd. — 6 clearances - Pharmacia, Inc. — 5 clearances - Behring Diagnostics, Inc. — 3 clearances - Diagnostic Products Corp. — 3 clearances - Diagnostic Systems Laboratories, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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