LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | LBS |
|---|---|
| Device Name | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (80)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162593 | HDL-Cholesterol Gen.4 | Roche Diagnostics Operations (Rdo) | Oct 19, 2016 | SESE |
| K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | Jan 8, 2016 | SESE |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | Carolina Liquid Chemistries Corp. | May 8, 2014 | SESE |
| K120609 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | Ortho-Clinical Diagnostics, Inc. | Sep 7, 2012 | SESE |
| K111516 | NMR LIPOPROFILE (R) TEST AND NMR PROFILER | Liposcience, Inc. | Sep 27, 2011 | SESE |
| K103747 | ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS | Elitechgroup Seppim S.A.S. | Aug 31, 2011 | SESE |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT | Medica Corporation | Jul 12, 2011 | SESE |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC | Polymedco, Inc. | Sep 28, 2010 | SESE |
| K100010 | HDL CHOLESTEROL (HDLX) ASSAY | Beckman Coulter, Inc. | May 14, 2010 | SESE |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | Wako Chemicals USA, Inc. | Jul 18, 2008 | SESE |
| K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 | Medica Corp. | Apr 14, 2008 | SESE |
| K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS | Diazyme Laboratories | Jan 3, 2008 | SESE |
| K072836 | CHOLESTRAK HDL CHOLESTEROL HOME TEST | Accutech, LLC | Dec 27, 2007 | SESE |
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | Clinical Data, Inc. | Dec 20, 2007 | SESE |
| K062092 | PREVU POINT OF CARE SKIN STEROL TEST | Premd, Inc. | Sep 15, 2006 | SESU |
| K053157 | AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A | Dade Behring, Inc. | Dec 9, 2005 | SESE |
| K051962 | ULTRA HDL | Abbott Laboratories | Aug 25, 2005 | SESE |
| K050632 | ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY | Bayer Healthcare, LLC | May 26, 2005 | SESE |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | Diagnostic Chemicals , Ltd. | Nov 23, 2004 | SESE |
| K041090 | HDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | Oct 29, 2004 | SESE |
| K042006 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE | Ortho-Clinical Diagnostics, Inc. | Oct 28, 2004 | SESE |
| K042195 | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 | Beckman Coulter, Inc. | Sep 16, 2004 | SESE |
| K040767 | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT | Beckman Coulter, Inc. | Jun 7, 2004 | SESE |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | Stanbio Laboratory | Mar 10, 2004 | SESE |
| K033610 | HDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | Dec 5, 2003 | SESE |
| K023640 | PICCOLO HDL TEST SYSTEM | Abaxis, Inc. | Jan 24, 2003 | SESE |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | Genzyme Corp. | Jul 25, 2002 | SESE |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | Jas Diagnostics, Inc. | Jul 19, 2002 | SESE |
| K014018 | CHOLESTEROL 1, 2, 3 | Imi | Jun 24, 2002 | SESU |
| K014032 | OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA | Olympus America, Inc. | Feb 8, 2002 | SESE |
| K014015 | OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA | Olympus America, Inc. | Feb 8, 2002 | SESE |
| K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS | Elan Holdings, Inc. | Nov 9, 2001 | SESE |
| K012286 | MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | Aug 8, 2001 | SESE |
| K991664 | LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 | A.P. Total Care, Inc. | Aug 19, 1999 | SESE |
| K991665 | HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 | A.P. Total Care, Inc. | Aug 10, 1999 | SESE |
| K990581 | DIRECT HDL-CHOLESTEROL REAGENT | Kamiya Biomedical Co. | Jun 18, 1999 | SESE |
| K982539 | HDLC PRECIPITATING REAGENT | Ac Biochemicals, Inc. | Sep 15, 1998 | SESE |
| K981224 | DIRECT HDL | Abbott Laboratories | Aug 3, 1998 | SESE |
| K982341 | DIRECT HDL-CHOLESTROL LIQUID | Randox Laboratories, Ltd. | Jul 30, 1998 | SESE |
| K981899 | CARESIDE HDL-CHOLESTEROL | Exigent Diagnostics, Inc. | Jul 14, 1998 | SESE |
| K981580 | HDL | Abbott Laboratories | Jun 11, 1998 | SESE |
| K973988 | RDI HOMOGENEOUS HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | Dec 22, 1997 | SESE |
| K972041 | EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) | Sigma Diagnostics, Inc. | Jul 22, 1997 | SESE |
| K971902 | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT | Roche Diagnostic Systems, Inc. | Jun 16, 1997 | SESE |
| K971190 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | Genzyme Corp. | Jun 16, 1997 | SESE |
| K971162 | LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR | Genzyme Corp. | Jun 16, 1997 | SESE |
| K970735 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | Randox Laboratories, Ltd. | Jun 6, 1997 | SESE |
| K971526 | ACE HDL-C REAGENT | Schiapparelli Biosystems, Inc. | May 21, 1997 | SESE |
| K963213 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | Boehringer Mannheim Corp. | Oct 23, 1996 | SESE |
| K954778 | CHOLESTECH LDX SYSTEM | Cholestech Corp. | Nov 24, 1995 | SESE |
| K943279 | ACCUMETER HDL CHOLESTEROL TEST | Chemtrak, Inc. | May 1, 1995 | SESE |
| K943028 | HDL QVET | Prisma Systems | Dec 7, 1994 | SESE |
| K934045 | BECKMAN HDL CHOLESTEROL REAGENT | Beckman Instruments, Inc. | Oct 14, 1993 | SESE |
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | Technicon Instruments Corp. | Nov 27, 1991 | SESE |
| K905296 | CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL | Cholestech Corp. | Dec 26, 1990 | SESE |
| K900036 | IMMUNOTECH HDL-CHOLESTEROL TEST | Immunotech Corp. | Mar 9, 1990 | SESE |
| K895139 | CLINISTAT HDL CHOLESTEROL REAGENT TEST | Heraeus Kulzer, Inc. | Dec 27, 1989 | SESE |
| K895851 | SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT | Beckman Instruments, Inc. | Nov 29, 1989 | SESE |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | Photec Diagnostics, Inc. | Aug 31, 1989 | SESE |
| K893548 | SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP | Heraeus Kulzer, Inc. | Aug 3, 1989 | SESE |
| K881891 | IQ HDL CHOLESTEROL | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 10, 1988 | SESE |
| K874397 | EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 | Em Diagnostic Systems, Inc. | Nov 24, 1987 | SESE |
| K871265 | ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL | E.I. Dupont DE Nemours & Co., Inc. | Aug 13, 1987 | SESE |
| K872050 | PARAMAX CHOLESTEROL REAGENT | American Dade | Jul 7, 1987 | SESE |
| K871461 | VISION (TM) HDL CHOLESTEROL | Abbott Laboratories | May 14, 1987 | SESE |
| K864522 | ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE | Beckman Instruments, Inc. | Feb 4, 1987 | SESE |
| K861244 | HDL/CHOLESTEROL TEST SYSTEM | Chrometrics Laboratories, Inc. | Sep 29, 1986 | SESE |
| K862845 | EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 | Em Diagnostic Systems, Inc. | Aug 29, 1986 | SESE |
| K843029 | HIGH DENSITY LIPOPROTEIN PRECIPITATIN | Diagnostic Chemicals, Ltd. (Usa) | Aug 27, 1984 | SESE |
| K840677 | HDL EZ-TZ3 CHOLESTEROL REAGENT KIT | Preventive Diagnostics Corp. | Apr 13, 1984 | SESE |
| K840676 | PDC HDL EZ-SEP CHOLESTEROL REAGENT | Preventive Diagnostics Corp. | Apr 4, 1984 | SESE |
| K813192 | HDL-C EIKEN | Syn-Kit, Inc. | Nov 27, 1981 | SESE |
| K801834 | WAKO HDL CHOLESTEROL TEST | Wako Pure Chemical Industries, Ltd. | Sep 16, 1980 | SESE |
| K801726 | HDL CHOLESTEROL TEST KIT | Mallinckrodt Critical Care | Sep 9, 1980 | SESE |
| K801133 | CENTRIFICHEM HDL CHOLESTEROL | Union Carbide Corp. | Jun 17, 1980 | SESE |
| K792319 | COULTER HDL CHOLESTEROL REAG. SYSTEM | Coulter Electronics, Inc. | Dec 6, 1979 | SESE |
| K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO | Dade, Baxter Travenol Diagnostics, Inc. | Nov 13, 1979 | SESE |
| K791990 | TECHNICON HDL CHOLESTEROL METHOD | Technicon Instruments Corp. | Oct 17, 1979 | SESE |
| K790553 | CHOLESTEROL KIT, HDL-DS | Beckman Instruments, Inc. | Jun 15, 1979 | SESE |
| K790281 | DIAGNOSTIC SET, LIPO-FRAX | Analytical Products, Inc. | Mar 21, 1979 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 4 clearances
- Abbott Laboratories — 4 clearances
- Randox Laboratories, Ltd. — 3 clearances
- Genzyme Corp. — 3 clearances
- Beckman Coulter, Inc. — 3 clearances
