Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5130](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5130) → DEM — Alpha-1-Antitrypsin, Antigen, Antiserum, Control # DEM · Alpha-1-Antitrypsin, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5130 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM ## Overview - **Product Code:** DEM - **Device Name:** Alpha-1-Antitrypsin, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5130](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5130) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K123256](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K123256.md) | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | The Binding Site Group , Ltd. | Jul 3, 2013 | SESE | | [K063610](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K063610.md) | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | Jan 11, 2007 | SESE | | [K053072](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K053072.md) | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | Dade Behring, Inc. | Mar 28, 2006 | SESE | | [K052819](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K052819.md) | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | Dec 23, 2005 | SESE | | [K050596](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K050596.md) | QUANTIA A1-AT | Biokit, S.A. | May 13, 2005 | SESE | | [K031857](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K031857.md) | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Bayer Diagnostics Corp. | Sep 4, 2003 | SESE | | [K011663](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K011663.md) | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | The Binding Site, Ltd. | Jul 30, 2001 | SESE | | [K010978](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K010978.md) | TINA-QUANT ALPHA-1 ANTITRYPSIN | Rochdiag | May 18, 2001 | SESE | | [K993444](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K993444.md) | K-ASSAY ALPHA-1 AT | Kamiya Biomedical Co. | Nov 24, 1999 | SESE | | [K972640](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K972640.md) | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY | Boehringer Mannheim Corp. | Jan 9, 1998 | SESE | | [K973392](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K973392.md) | CHEMMATE LAMBDA | Ventana Medical Systems, Inc. | Oct 3, 1997 | SESE | | [K973391](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K973391.md) | CHEMMATE KAPPA | Ventana Medical Systems, Inc. | Oct 3, 1997 | SESE | | [K973390](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K973390.md) | CHEMMATE L26 (CD20) | Ventana Medical Systems, Inc. | Oct 3, 1997 | SESE | | [K973389](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K973389.md) | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | Ventana Medical Systems, Inc. | Oct 3, 1997 | SESE | | [K965100](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K965100.md) | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE | | [K964766](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K964766.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | Beckman Instruments, Inc. | Apr 25, 1997 | SESE | | [K931979](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K931979.md) | VENTANA NEGATIVE CONTROL REAGENT | Ventana Medical Systems, Inc. | Mar 30, 1994 | SESE | | [K920005](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K920005.md) | IL TEST ALPHA-1-ANTITRYPSIN (AAT) | Instrumentation Laboratory CO | Jul 29, 1992 | SESE | | [K913666](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K913666.md) | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | Dec 9, 1991 | SESE | | [K890415](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM/K890415.md) | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Atlantic Antibodies | Feb 17, 1989 | SESE | ## Top Applicants - Ventana Medical Systems, Inc. — 5 clearances - Dade Behring, Inc. — 2 clearances - Kallestad Diag, A Div. of Erbamont, Inc. — 2 clearances - The Binding Site, Ltd. — 2 clearances - Applications Lab — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEM) **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