Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5040](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5040) → DCF — Albumin, Antigen, Antiserum, Control # DCF · Albumin, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF ## Overview - **Product Code:** DCF - **Device Name:** Albumin, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5040](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5040) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) ## Identification An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. ## 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 § 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 § 866.9. ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K153560](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K153560.md) | Optilite Low Level Albumin Kit | The Binding Site Group , Ltd. | Aug 25, 2016 | SESE | | [K143118](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K143118.md) | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group , Ltd. | May 26, 2015 | SESE | | [K142346](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K142346.md) | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Beckman Coulter Ireland, Inc. | Oct 15, 2014 | SESE | | [K121045](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K121045.md) | HUMAN ALBUMIN CSF KIT | The Binding Site Group , Ltd. | Jun 19, 2013 | SESE | | [K113072](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K113072.md) | TINA-QUANT ALBUMIN GEN.2 | Roche Diagnostics Operations | May 14, 2012 | SESE | | [K101089](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K101089.md) | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | Medica Corp. | Jul 13, 2011 | SESE | | [K101203](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K101203.md) | TINA-QUANT ALBUMIN GEN 2 | Roche Diagnostics | Sep 10, 2010 | SESE | | [K100853](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K100853.md) | COBAS 8000 MODULAR SERIES ANALYZER | Roche Diagnostics Corp. | Sep 9, 2010 | SESE | | [K091486](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K091486.md) | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | Kamiya Biomedical Co. | Apr 29, 2010 | SESE | | [K082251](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K082251.md) | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | Beckman Coulter, Inc. | Apr 8, 2009 | SESE | | [K061990](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K061990.md) | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL | Dade Behring, Inc. | Sep 19, 2006 | SESE | | [K053553](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K053553.md) | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | Polymedco, Inc. | Mar 9, 2006 | SESE | | [K051191](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K051191.md) | DCL MICROALBUMIN ASSAY, MODEL 252-20 | Diagnostic Chemicals , Ltd. | Jul 5, 2005 | SESE | | [K042643](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K042643.md) | VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | Nov 18, 2004 | SESE | | [K033525](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K033525.md) | DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 | Dade Behring, Inc. | Jan 12, 2004 | SESE | | [K972929](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K972929.md) | N ANTISERUM TO HUMAN ALBUMIN | Behring Diagnostics, Inc. | Oct 20, 1997 | SESE | | [K964695](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K964695.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT | Beckman Instruments, Inc. | Apr 29, 1997 | SESE | | [K961824](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K961824.md) | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN | Roche Diagnostic Systems, Inc. | Jul 23, 1996 | SESE | | [K953927](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K953927.md) | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | International Enzymes, Inc. | Sep 15, 1995 | SESE | | [K914391](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF/K914391.md) | ALBUMIN TEST RID KIT | The Binding Site, Ltd. | Dec 10, 1991 | SESE | ## Top Applicants - Kallestad Diag, A Div. of Erbamont, Inc. — 4 clearances - The Binding Site Group , Ltd. — 3 clearances - Unipath , Ltd. — 2 clearances - Technicon Instruments Corp. — 2 clearances - Dade Behring, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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