Ldl & Vldl Precipitation, Hdl
FDA product code LBR · Class I (low risk) · 21 CFR 862.1475 · Clinical Chemistry
66510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Pointe Scientific, Inc., 3
- Merchant House Scientific 3
- Genzyme Corp. 3
- Trace America, Inc. 2
- Roche Diagnostic Systems, Inc. 2
- Reference Diagnostics, Inc. 2
- Boehringer Mannheim Corp. 2
- Diagnostic Chemicals , Ltd. 2
- Preventive Diagnostics Corp. 2
- American Monitor Corp. 2
- Ortho-Clinical Diagnostics 2
- Reagents Applications, Inc. 1
- Roche Diagnostics Operations (Rdo) 1
- Data Medical Associates, Inc. 1
- Livonia Diagnostics, Inc. 1
- Anco Medical Reagents & Assoc. 1
- Gilford Diagnostics 1
- Sclavo, Inc. 1
- Sherwood Medical Co. 1
- Abbott Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3LBR · Traditional | Roche Diagnostics Operations (Rdo) | 01/28/2015SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | General Atomics | 01/22/2008SE |
| K050823 | Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional | Teco Diagnostics | 07/26/2005SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | Hemagen Diagnostics, Inc. | 12/24/2002SE |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special | Ortho-Clinical Diagnostics, Inc. | 08/30/2001SE |
| K992029 | Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Diagnostics | 08/12/1999SE |
| K992002 | Autohdl Cholesterol Reagent SetLBR · Traditional | Pointe Scientific, Inc., | 08/05/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Holdings, Inc. | 07/09/1999SE |
| K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional | Polymer Technology Systems, Inc. | 05/28/1999SE |
| K984303 | Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/28/1999SE |
| K980772 | Hdl-Cholesterol Precipitating Reagent, Catalogue Number 205-51LBR · Traditional | Diagnostic Chemicals , Ltd. | 04/27/1998SE |
| K980770 | HDL Uni-Paks (Pta), Catalogue Number 215-51LBR · Traditional | Diagnostic Chemicals , Ltd. | 04/21/1998SE |
| K974733 | Boehringer Mannheim Direct LDL - CholesterolLBR · Traditional | Boehringer Mannheim Corp. | 01/26/1998SE |
| K973369 | Roche Unimate HDL Direct Reagen (with Pol Claim)LBR · Traditional | Roche Diagnostic Systems, Inc. | 11/21/1997SE |
| K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL…LBR · Traditional | Genzyme Corp. | 06/18/1997SE |
| K962723 | Trace HDL Cholesterol - Automated (HomogenLBR · Traditional | Trace America, Inc. | 03/13/1997SE |
| K962186 | N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorLBR · Traditional | Genzyme Corp. | 08/19/1996SE |
| K954179 | HDL Precipitating ReagentLBR · Traditional | Schiapparelli Biosystems, Inc. | 12/11/1995SE |
| K944975 | Magnetic HDL Cholesterol TestLBR · Traditional | Reference Diagnostics, Inc. | 08/02/1995SE |
| K941744 | Pbi Plus HDL Precipitating ReagentLBR · Traditional | Merchant House Scientific | 09/06/1994SE |
| K932766 | Hdl-Cholestral(Dextran Sulfate/Magnesium)LBR · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 12/10/1993SE |
| K934961 | Spinpro HDL Precipitating ReagentLBR · Traditional | Merchant House Scientific | 12/09/1993SE |
| K934801 | Spinpro HDL Precipitating ReagentLBR · Traditional | Merchant House Scientific | 12/07/1993SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | Intersect Systems, Inc. | 11/16/1993SE |
| K931773 | HDL Precipitating Reagent (Dextran Sulfate)LBR · Traditional | King Diagnostics, Inc. | 08/16/1993SE |
| K924427 | Synermed HDL Cholestlerol Reagent KitLBR · Traditional | Synermed, Inc. | 11/09/1992SE |
| K914811 | Il Test(Tm) HDL CholesterolLBR · Traditional | Instrumentation Laboratory CO | 01/09/1992SE |
| K912823 | High Density Lipoprotein CholesterolLBR · Traditional | Creative Laboratory Products, Inc. | 08/16/1991SE |
| K911906 | Magnetic HDL Cholesterol TestLBR · Traditional | Reference Diagnostics, Inc. | 07/18/1991SE |
| K911406 | HDL Cholesterol ReagentLBR · Traditional | Genzyme Corp. | 05/22/1991SE |
| K903733 | Ica Plasma HDL and LDL Measurement SystemLBR · Traditional | Institute For Clinical Applications | 01/15/1991SE |
| K905284 | Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional | Amresco, Inc. | 12/11/1990SE |
| K904184 | Biotrol HDL Cholesterol Precipitation ReagentLBR · Traditional | Biotron U.S.A., Inc. | 11/28/1990SE |
| K903094 | Stat Test Hdl/Cholesterol Test KitLBR · Traditional | Diagnostic Resources, Inc. | 08/29/1990SE |
| K902568 | Reflotron HDL Cholesterol Test TabsLBR · Traditional | Boehringer Mannheim Corp. | 08/09/1990SE |
| K902174 | Coulter HDL - Cholesterol ReagentLBR · Traditional | Coulter Corp. | 07/31/1990SE |
| K900120 | Roche Separating Reagent for HDL CholesterolLBR · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1990SE |
| K895381 | HDL SinglesLBR · Traditional | Trace America, Inc. | 11/08/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | Diagnostic Systems | 07/25/1989SE |
| K891117 | HDL Cholesterol ReagentLBR · Traditional | Pointe Scientific, Inc., | 04/10/1989SE |
| K890669 | Statspin Hdl-Cholesterol Precipitating Micro TubeLBR · Traditional | Norfolk Scientific, Inc. | 03/08/1989SE |
| K890023 | HDL Cholesterol Reagent (PTA/MGCL2)LBR · Traditional | Sigma Diagnostics, Inc. | 02/17/1989SE |
| K885265 | HDL Cholesterol TestLBR · Traditional | Em Diagnostic Systems, Inc. | 02/10/1989SE |
| K883353 | Iq HDL CholesterolLBR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/13/1988SE |
| K882488 | Cantrol HDL Cholesterol Precipi. Reag. and TubesLBR · Traditional | Canyon Diagnostics, Inc. | 08/15/1988SE |
| K881244 | HDL Cholesterol KitLBR · Traditional | Trace Scientific , Ltd. | 06/10/1988SE |
| K881326 | HDL Cholesterol Precipitating ProcedureLBR · Traditional | Data Medical Associates, Inc. | 05/27/1988SE |
| K880176 | HDL Cholesterol Precipitating ReagentLBR · Traditional | Tech-Co, Inc. | 02/18/1988SE |
| K874820 | Multichem HDL Precipitating Reagent #S0914LBR · Traditional | Simmler, Inc. | 01/07/1988SE |
| K861926 | Worthington HDL Precipitating Reagent SetLBR · Traditional | Cooper Biomedical, Inc. | 06/27/1986SE |
| K852350 | HDL Cholesterol PretreatmentLBR · Traditional | American Monitor Corp. | 07/08/1985SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | Livonia Diagnostics, Inc. | 11/02/1984SE |
| K834251 | HDL Cholesterol PretreatmentLBR · Traditional | American Monitor Corp. | 02/13/1984SE |
| K833160 | HDL Ez-TabLBR · Traditional | Preventive Diagnostics Corp. | 02/09/1984SE |
| K833431 | HDL Ex-Sep Precipitating ReagentLBR · Traditional | Preventive Diagnostics Corp. | 01/13/1984SE |
| K830207 | Raichem Hdl-Cholesterol ReagentLBR · Traditional | Reagents Applications, Inc. | 03/21/1983SE |
| K821203 | HDL Precipitant Reagent SetLBR · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K812839 | HDL Cholesterol Reagent SetLBR · Traditional | Anco Medical Reagents & Assoc. | 12/03/1981SE |
| K812574 | HDL Cholesterol ReagentLBR · Traditional | Pointe Scientific, Inc., | 09/24/1981SE |
| K800996 | HDL ReagentLBR · Traditional | Gilford Diagnostics | 05/14/1980SE |
| K792313 | Chol-Hdl Test, High Lipo. Chol TestLBR · Traditional | Sclavo, Inc. | 12/07/1979SE |
| K790865 | Lancer HDL Separation KitLBR · Traditional | Sherwood Medical Co. | 06/28/1979SE |
| K790372 | H-D-ElLBR · Traditional | General Diagnostics | 05/03/1979SE |
| K790329 | A-Gent-Hdl ReagentLBR · Traditional | Abbott Laboratories | 04/04/1979SE |
| K781093 | HDL CentrifikitLBR · Traditional | Beckman Instruments, Inc. | 08/14/1978SE |
| K780542 | AlfatestLBR · Traditional | Panmed, Inc. | 05/19/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0389-2019 Class III | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product…Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | Medtest Holdings, Inc. | 08/10/2018Terminated |
| Z-0930-2017 Class III | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | Sterling Diagnostics, Inc. | 07/20/2016Terminated |
| Z-1928-2015 Class II | LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | Roche Diagnostics Operations, Inc. | 05/07/2015Terminated |
| Z-2764-2015 Class III | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE…Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during… | Pointe Scientific, Inc. | 03/13/2015Terminated |
| Z-0860-2010 | Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog #…The firm initiated the recall due to the presence of visible contamination of the product. | Pointe Scientific, Inc. | 11/10/2009Terminated |
| Z-0859-2010 | Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set…The firm initiated the recall due to the presence of visible contamination of the product. | Pointe Scientific, Inc. | 11/10/2009Terminated |
| Z-1201-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc.…The R1 reagent has microbial contamination. | Pointe Scientific, Inc. | 01/29/2009Terminated |
| Z-1200-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc.…The R1 reagent has microbial contamination. | Pointe Scientific, Inc. | 01/29/2009Terminated |
| Z-0076-2007 | Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit…Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | Stanbio Laboratory, Inc | 09/18/2006Terminated |
| Z-0075-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit…Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | Stanbio Laboratory, Inc | 09/18/2006Terminated |
| Z-0074-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit…Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | Stanbio Laboratory, Inc | 09/18/2006Terminated |