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) → CZP — Iga, Antigen, Antiserum, Control # CZP · Iga, 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/CZP ## Overview - **Product Code:** CZP - **Device Name:** Iga, 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 54) Showing 20 most recent of 54 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K193525](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K193525.md) | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | Jun 26, 2020 | SESE | | [K060130](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K060130.md) | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | Beckman Coulter, Inc. | Feb 13, 2006 | SESE | | [K040435](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K040435.md) | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | Roche Diagnostics Corp. | Mar 10, 2004 | SESE | | [K024038](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K024038.md) | N LATEX IGA | Dade Behring, Inc. | Feb 13, 2003 | SESE | | [K993927](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K993927.md) | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | Wako Chemicals USA, Inc. | Jan 14, 2000 | SESE | | [K983359](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K983359.md) | IGA | Abbott Laboratories | Nov 4, 1998 | SESE | | [K962200](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K962200.md) | QUANTEX IGA | Instrumentation Laboratory CO | Sep 25, 1996 | SESE | | [K955794](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K955794.md) | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | Apr 5, 1996 | SESE | | [K955907](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K955907.md) | BOEHRINGER MANNHEIM IGA ASSAY | Boehringer Mannheim Corp. | Feb 9, 1996 | SESE | | [K952309](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K952309.md) | N LATEX IGA | Behring Diagnostics, Inc. | Jun 20, 1995 | SESE | | [K931806](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K931806.md) | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | Jul 16, 1993 | SESE | | [K920014](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K920014.md) | IL TEST IMMUNOGLOBULIN A | Instrumentation Laboratory CO | Jun 16, 1992 | SESE | | [K900422](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K900422.md) | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 | Helena Laboratories | Feb 27, 1990 | SESE | | [K894418](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K894418.md) | RAICHEM(TM) SPIA(TM) IGA REAGENTS | Reagents Applications, Inc. | Aug 2, 1989 | SESE | | [K890560](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K890560.md) | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Atlantic Antibodies | Feb 15, 1989 | SESE | | [K884040](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K884040.md) | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Orion Diagnostica, Inc. | Oct 19, 1988 | SESE | | [K883492](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K883492.md) | TECHNICON DPA-1 IMMUNOGLOBULIN A | Technicon Instruments Corp. | Sep 22, 1988 | SESE | | [K880803](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K880803.md) | WAKO(TM) IGA-HA DIRECT | Wako Chemicals USA, Inc. | Mar 29, 1988 | SESE | | [K873869](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K873869.md) | IMMUNOGLOBULINS A | Unipath , Ltd. | Oct 13, 1987 | SESE | | [K871940](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K871940.md) | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL | Kallestad Diag, A Div. of Erbamont, Inc. | Jun 12, 1987 | SESE | ## Top Applicants - Kallestad Laboratories, Inc. — 3 clearances - Boehringer Mannheim Corp. — 3 clearances - Abbott Laboratories — 3 clearances - Wako Chemicals USA, Inc. — 2 clearances - Syva Co. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com