Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5580](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5580) → DER — Alpha-1-Lipoprotein, Antigen, Antiserum, Control # DER · Alpha-1-Lipoprotein, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER ## Overview - **Product Code:** DER - **Device Name:** Alpha-1-Lipoprotein, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5580](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5580) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K013249](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K013249.md) | TINA-QUANT APOLIPOPROTEIN VER.2 | Roche Diagnostics Corp. | Nov 16, 2001 | SESE | | [K000921](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K000921.md) | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | May 18, 2000 | SESE | | [K993354](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K993354.md) | K-ASSAY APO B | Kamiya Biomedical Co. | Oct 28, 1999 | SESE | | [K993345](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K993345.md) | K-ASSAY APO AI | Kamiya Biomedical Co. | Oct 25, 1999 | SESE | | [K990594](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K990594.md) | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Roche Diagnostics Corp. | Apr 14, 1999 | SESE | | [K983289](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K983289.md) | APOLIPOPROTEIN A1 | Abbott Laboratories | Jan 29, 1999 | SESE | | [K964296](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K964296.md) | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | Aug 1, 1997 | SESE | | [K964294](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K964294.md) | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | Aug 1, 1997 | SESE | | [K964292](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K964292.md) | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | Aug 1, 1997 | SESE | | [K910553](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K910553.md) | ROCHE APOLIPOPROTEIN STANDARD | Roche Diagnostic Systems, Inc. | May 8, 1991 | SESE | | [K904125](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K904125.md) | UC IMU A | Eucardio Laboratory, Inc. | Sep 24, 1990 | SESE | | [K872078](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K872078.md) | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Solomon Park Research Laboratories | Jun 18, 1987 | SESE | | [K854875](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K854875.md) | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | Jan 24, 1986 | SESE | | [K853048](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K853048.md) | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Photec Diagnostics, Inc. | Aug 28, 1985 | SESE | | [K851649](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K851649.md) | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | Jun 5, 1985 | SESE | | [K840830](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K840830.md) | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | Ventrex Laboratories, Inc. | May 21, 1984 | SESE | | [K802610](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K802610.md) | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Hyland Therapeutic Div., Travenol Laboratories | Jan 5, 1981 | SESE | ## Top Applicants - Photec Diagnostics, Inc. — 3 clearances - Crestat Diagnostics, Inc. — 3 clearances - Roche Diagnostics Corp. — 2 clearances - Kamiya Biomedical Co. — 2 clearances - Ventrex Laboratories, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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