Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5600](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5600) → DFC — Lipoprotein, Low-Density, Antigen, Antiserum, Control # DFC · Lipoprotein, Low-Density, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5600 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC ## Overview - **Product Code:** DFC - **Device Name:** Lipoprotein, Low-Density, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5600](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5600) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 42) Showing 20 most recent of 42 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241220](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K241220.md) | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | Jan 24, 2025 | SESE | | [K211058](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K211058.md) | Lp(a) Ultra | SENTINEL CH. SpA | Dec 22, 2022 | SESE | | [K180074](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K180074.md) | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | Mar 22, 2018 | SESE | | [K123046](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K123046.md) | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Dec 20, 2012 | SESE | | [K122722](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K122722.md) | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 | Roche Diagnostics | Nov 29, 2012 | SESE | | [K082488](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K082488.md) | DIAZYME LP(A) ASSAY | General Atomics | Jan 13, 2009 | SESE | | [K063838](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K063838.md) | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | Thermo Electron OY | Sep 27, 2007 | SESE | | [K050487](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K050487.md) | QUANTIA LA(A) | Biokit, S.A. | Apr 26, 2005 | SESE | | [K023853](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K023853.md) | K-ASSAY LP(A) CONTROLS | Kamiya Biomedical Co. | Dec 13, 2002 | SESE | | [K021660](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K021660.md) | K-ASSAY LP(A) ASSAY | Kamiya Biomedical Co. | Jul 25, 2002 | SESE | | [K013359](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K013359.md) | LP(A)-LATEX SEIKEN ASSAY KIT | Denka Seiken'S | Mar 8, 2002 | SESE | | [K013128](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K013128.md) | N LATEX LP(A) | Dade Behring, Inc. | Jan 18, 2002 | SESE | | [K013206](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K013206.md) | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | Nov 16, 2001 | SESE | | [K013207](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K013207.md) | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | Nov 13, 2001 | SESE | | [K001934](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001934.md) | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE | | [K001933](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001933.md) | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE | | [K001931](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001931.md) | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE | | [K001929](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001929.md) | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE | | [K001921](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001921.md) | WAKO AUTOKIT LP(A)/EXPRESS 550 | Wako Chemicals USA, Inc. | Jul 23, 2000 | SESE | | [K001920](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001920.md) | WAKO AUTOKIT LP(A)/ RA,500/1000, | Wako Chemicals USA, Inc. | Jul 23, 2000 | SESE | ## Top Applicants - Wako Chemicals USA, Inc. — 9 clearances - Roche Diagnostics Corp. — 3 clearances - DiaSorin, Inc. — 3 clearances - Kamiya Biomedical Co. — 2 clearances - Kallestad Diag, A Div. of Erbamont, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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