DFC · Lipoprotein, Low-Density, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5600 · Class 2
Overview
| Product Code | DFC |
|---|---|
| Device Name | Lipoprotein, Low-Density, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5600 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 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 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | Jan 24, 2025 | SESE |
| K211058 | Lp(a) Ultra | SENTINEL CH. SpA | Dec 22, 2022 | SESE |
| K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | Mar 22, 2018 | SESE |
| K123046 | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Dec 20, 2012 | SESE |
| K122722 | 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 | DIAZYME LP(A) ASSAY | General Atomics | Jan 13, 2009 | SESE |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | Thermo Electron OY | Sep 27, 2007 | SESE |
| K050487 | QUANTIA LA(A) | Biokit, S.A. | Apr 26, 2005 | SESE |
| K023853 | K-ASSAY LP(A) CONTROLS | Kamiya Biomedical Co. | Dec 13, 2002 | SESE |
| K021660 | K-ASSAY LP(A) ASSAY | Kamiya Biomedical Co. | Jul 25, 2002 | SESE |
| K013359 | LP(A)-LATEX SEIKEN ASSAY KIT | Denka Seiken'S | Mar 8, 2002 | SESE |
| K013128 | N LATEX LP(A) | Dade Behring, Inc. | Jan 18, 2002 | SESE |
| K013206 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | Nov 16, 2001 | SESE |
| K013207 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | Nov 13, 2001 | SESE |
| K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE |
| K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE |
| K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE |
| K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | Wako Chemicals USA, Inc. | Jul 24, 2000 | SESE |
| K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 | Wako Chemicals USA, Inc. | Jul 23, 2000 | SESE |
| K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, | Wako Chemicals USA, Inc. | Jul 23, 2000 | SESE |
Top Applicants
- Wako Chemicals USA, Inc. — 9 clearances
- DiaSorin, Inc. — 3 clearances
- Roche Diagnostics Corp. — 3 clearances
- Kallestad Diag, A Div. of Erbamont, Inc. — 2 clearances
- Kamiya Biomedical Co. — 2 clearances
