Lipoprotein, Low-Density, Antigen, Antiserum, Control
FDA product code DFC · Class II (moderate risk) · 21 CFR 866.5600 · Immunology
43510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Wako Chemicals USA, Inc. 9
- Roche Diagnostics Corp. 4
- DiaSorin, Inc. 3
- Diazyme Laboratories 2
- Kamiya Biomedical Co. 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Axis Biochemicals, Asa 1
- Roche Diagnostics Operations, Inc. 1
- Dade Behring, Inc. 1
- Beckman Coulter Inc. 1
- Diasorin/American Standard Companies 1
- Trinity Biotech USA 1
- Abbott Laboratories 1
- Gelman Instrument Co. 1
- Perimmune, Inc. 1
- Instrumentation Laboratory CO 1
- Eucardio Laboratory, Inc. 1
- Binax, Inc. 1
- Reagents Applications, Inc. 1
- Icl Scientific 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | Diazyme Laboratories, Inc. | 06/16/2026SE |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | Roche Diagnostics Operations | 01/24/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | SENTINEL CH. SpA | 12/22/2022SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | Diazyme Laboratories, Inc. | 03/22/2018SE |
| K123046 | Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) CalibratorDFC · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/20/2012SE |
| K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional | Roche Diagnostics | 11/29/2012SE |
| K082488 | Diazyme Lp(A) AssayDFC · Traditional | General Atomics | 01/13/2009SE |
| K063838 | Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional | Thermo Electron OY | 09/27/2007SE |
| K050487 | Quantia La(A)DFC · Traditional | Biokit, S.A. | 04/26/2005SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | Kamiya Biomedical Co. | 12/13/2002SE |
| K021660 | K-Assay Lp(A) AssayDFC · Traditional | Kamiya Biomedical Co. | 07/25/2002SE |
| K013359 | Lp(A)-Latex Seiken Assay KitDFC · Traditional | Denka Seiken'S | 03/08/2002SE |
| K013128 | N Latex Lp(A)DFC · Traditional | Dade Behring, Inc. | 01/18/2002SE |
| K013206 | Tina-Quant Apolipoprotein B VER.2DFC · Traditional | Roche Diagnostics Corp. | 11/16/2001SE |
| K013207 | Tina-Quant Apolipoprotein B VER.2DFC · Traditional | Roche Diagnostics Corp. | 11/13/2001SE |
| K001934 | Wako Autokit Lp(A) & Lp(A) Calibrator/Beckman CXDFC · Special | Wako Chemicals USA, Inc. | 07/24/2000SE |
| K001933 | Wako Autokit Lp(A) & Lp(A) Calibrator/Cobas BioDFC · Special | Wako Chemicals USA, Inc. | 07/24/2000SE |
| K001931 | Wako Autokit Lp(A) & Lp(A) Calibrator/AerosetDFC · Special | Wako Chemicals USA, Inc. | 07/24/2000SE |
| K001929 | Wako Autokit Lp(A) and Lp(A) Calibrator/Cobas FaraDFC · Special | Wako Chemicals USA, Inc. | 07/24/2000SE |
| K001921 | Wako Autokit Lp(A)/Express 550DFC · Special | Wako Chemicals USA, Inc. | 07/23/2000SE |
| K001920 | Wako Autokit Lp(A)/ RA,500/1000,DFC · Special | Wako Chemicals USA, Inc. | 07/23/2000SE |
| K001919 | Wako Autokit Lp(A)/Dade DemensionDFC · Special | Wako Chemicals USA, Inc. | 07/23/2000SE |
| K000121 | Immage Immunochemistry System Lipoprotein(A) Lpax Reagent, Array System Lipoprotein(A)…DFC · Traditional | Beckman Coulter, Inc. | 05/17/2000SE |
| K001118 | Modification to Lipoprotein (a) SPQ III Antibody Reagent SetDFC · Special | DiaSorin, Inc. | 04/25/2000SE |
| K994110 | Lipoprotein (a) SPQ III Antibody Reagent SetDFC · Special | Diasorin/American Standard Companies | 12/21/1999SE |
| K992665 | Macra Lp(A) Enzyme Immunoassay KitDFC · Traditional | Trinity Biotech USA | 11/26/1999SE |
| K993669 | Lipoprotein (a) SPQ III Antibody Reagent SetDFC · Special | DiaSorin, Inc. | 11/17/1999SE |
| K990595 | Integra Reagent Cassette for Apolipoprotein BDFC · Traditional | Roche Diagnostics Corp. | 04/14/1999SE |
| K982708 | SPQ Test SystemDFC · Traditional | DiaSorin, Inc. | 04/02/1999SE |
| K981446 | Wako Autokit Lp(A)DFC · Traditional | Wako Chemicals USA, Inc. | 03/09/1999SE |
| K983281 | ApobDFC · Traditional | Abbott Laboratories | 01/26/1999SE |
| K980812 | Imx HomocysteineDFC · Traditional | Axis Biochemicals, Asa | 10/01/1998SE |
| K970302 | Apo-Tek Lp(A)DFC · Traditional | Perimmune, Inc. | 11/10/1997SE |
| K954657 | Wako Autokit Apo BDFC · Traditional | Wako Chemicals USA, Inc. | 12/20/1995SE |
| K923079 | Il Test Calibration Set Apo A1BDFC · Traditional | Instrumentation Laboratory CO | 02/05/1993SE |
| K904137 | Uc Imu BDFC · Traditional | Eucardio Laboratory, Inc. | 11/21/1990SE |
| K903122 | Equate(Tm) Aqr Apo Al/B Duo ControlDFC · Traditional | Binax, Inc. | 08/02/1990SE |
| K883712 | QM300 Control F PackDFC · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K883711 | QM300 Calibrator F PackDFC · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K872080 | Raichem(Tm) Spia(Tm) Apo B ReagentsDFC · Traditional | Reagents Applications, Inc. | 06/15/1987SE |
| K781015 | Anti-Human LDL SerumDFC · Traditional | Icl Scientific | 08/14/1978SE |
| K771912 | Las-R Beta Lipoprotein TestDFC · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 10/19/1977SE |
| K771812 | Lippoprotein Electrophoresis Reagent SetDFC · Traditional | Gelman Instrument Co. | 10/18/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1018-2025 Class II | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay…Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Randox Laboratories, Limited | 12/20/2024Open, Classified |
| Z-1017-2025 Class II | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay…Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Randox Laboratories, Limited | 12/20/2024Open, Classified |
| Z-1994-2019 Class II | Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | Abbott Laboratories, Inc | 05/16/2018Terminated |
| Z-1377-2012 | Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2…In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease. | Wako Chemicals USA, Inc. | 01/30/2012Terminated |