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.
Recent Cleared Devices (20 of 80)
Showing 20 most recent of 80 cleared devices.
| 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 |
Top Applicants
- Abbott Laboratories — 4 clearances
- Beckman Instruments, Inc. — 4 clearances
- Beckman Coulter, Inc. — 3 clearances
- Genzyme Corp. — 3 clearances
- Randox Laboratories, Ltd. — 3 clearances
