System, Test, Low Density, Lipoprotein
FDA product code MRR · Class I (low risk) · 21 CFR 862.1475 · Clinical Chemistry
31510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Reference Diagnostics, Inc. 4
- Genzyme Corp. 3
- Randox Laboratories, Ltd. 2
- Siemens Healthcare Diagnostics, Inc. 1
- Teco Diagnostics 1
- Denka Seiken Co., Ltd. 1
- Diagnostic Chemicals , Ltd. 1
- Ortho-Clinical Diagnostics 1
- Polymer Technology Systems, Inc. 1
- Hemagen Diagnostics, Inc. 1
- Dade Behring, Inc. 1
- Elan Diagnostics 1
- Beckman Coulter Inc. 1
- Roche Diagnostics Corp. 1
- Sigma Diagnostics, Inc. 1
- Schiapparelli Biosystems, Inc. 1
- Roche Diagnostic Systems, Inc. 1
- Wako Chemicals USA, Inc. 1
- Abbott Laboratories 1
- Pointe Scientific, Inc., 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)MRR · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/26/2024SE |
| K210801 | AXINON® LDL-p Test SystemMRR · Traditional | Numares AG | 07/19/2023SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | Randox Laboratories Limited | 03/20/2017SE |
| K091333 | S-Test LDL Cholesterol (LDL), Model RC0022MRR · Traditional | Alfa Wassermann, Inc. | 08/03/2009SE |
| K090734 | Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with ElectrolytesMRR · Traditional | Medica Corp. | 07/17/2009SE |
| K063841 | NMR Profiler and NMR Lipoprofile Assay, ControlsMRR · Traditional | Liposcience | 07/23/2008SE |
| K051121 | Direct LDL Cholesterol, Model L530-60HMRR · Traditional | Teco Diagnostics | 08/08/2005SE |
| K043264 | Ldl-Ex Seiken Assay KitMRR · Traditional | Denka Seiken Co., Ltd. | 01/26/2005SE |
| K041927 | Ldl/Advance Assay, Cat. No. 279-20, 279-40MRR · Traditional | Diagnostic Chemicals , Ltd. | 11/23/2004SE |
| K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…MRR · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/25/2004SE |
| K040693 | PTS Panels LDL Cholesterol Test StripsMRR · Traditional | Polymer Technology Systems, Inc. | 07/06/2004SE |
| K022772 | Raichem Ldl-Cholesterol Direct ReagentMRR · Traditional | Hemagen Diagnostics, Inc. | 09/17/2002SE |
| K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131MRR · Traditional | Dade Behring, Inc. | 05/09/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | Elan Diagnostics | 04/12/2002SE |
| K014103 | Synchron Systems Direct LDL Chloesterol Reagent and CalibratorMRR · Traditional | Beckman Coulter, Inc. | 01/28/2002SE |
| K012287 | Modification to: Cobas Integra Ldl-Cholesterol Plus 2ND GenerationMRR · Special | Roche Diagnostics Corp. | 08/07/2001SE |
| K993741 | Ez LDL Cholesterol Test SystemMRR · Traditional | Sigma Diagnostics, Inc. | 07/03/2000SE |
| K992766 | N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme…MRR · Traditional | Genzyme Corp. | 10/18/1999SE |
| K991733 | Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional | Schiapparelli Biosystems, Inc. | 07/13/1999SE |
| K984107 | Rdi Direct LDL Cholesterol TestMRR · Traditional | Reference Diagnostics, Inc. | 01/28/1999SE |
| K982848 | Cobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL DirectMRR · Traditional | Roche Diagnostic Systems, Inc. | 10/01/1998SE |
| K982271 | Wako Direct Ldl-CMRR · Traditional | Wako Chemicals USA, Inc. | 09/22/1998SE |
| K982529 | Randox Direct LDL CholesterolMRR · Traditional | Randox Laboratories, Ltd. | 09/11/1998SE |
| K981303 | Direct LDLMRR · Traditional | Abbott Laboratories | 08/03/1998SE |
| K981978 | Autoldl Cholesterol Reagent Set and Autoldl Cholesterol CalibratorMRR · Traditional | Pointe Scientific, Inc., | 07/22/1998SE |
| K964064 | Rdi Lipidirect Magnetic LDL ReagentMRR · Traditional | Reference Diagnostics, Inc. | 11/20/1996SE |
| K964063 | Rdi LDL Precipitation ReagentMRR · Traditional | Reference Diagnostics, Inc. | 11/20/1996SE |
| K955904 | Ektachem DT LDL Cholesterol KitMRR · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 05/24/1996SE |
| K943150 | Direct LDL Cholesterol Immunoseparation Reagent KitMRR · Traditional | Genzyme Corp. | 03/15/1995SE |
| K924674 | Direct LDL Choles Immunoseparation ReagentMRR · Traditional | Genzyme Corp. | 01/06/1993SE |
| K893740 | Lipidirect Low Density Lipoprotein Cholesterol TesMRR · Traditional | Reference Diagnostics, Inc. | 03/19/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0441-2026 Class II | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL… | Beckman Coulter Inc. | 09/17/2025Open, Classified |
| Z-1268-2023 Class II | Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination…Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and… | Siemens Healthcare Diagnostics, Inc. | 01/27/2023Open, Classified |
| Z-0476-2019 Class II | VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to…VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results | Ortho-Clinical Diagnostics | 10/08/2018Terminated |
| Z-1652-2016 Class II | Advia Chemistry Assay: LDL Cholesterol, DirectSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |
| Z-1927-2015 Class II | LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | Roche Diagnostics Operations, Inc. | 05/07/2015Terminated |
| Z-0006-2009 | Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | Roche Diagnostics Corp. | 06/11/2008Terminated |
| Z-1132-2010 | PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test…The expiration date was extended by 20 weeks without justification. | Polymer Technology Systems, Inc. | 05/29/2008Terminated |