CDT · Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Clinical Chemistry · 21 CFR 862.1705 · Class 1
Overview
| Product Code | CDT |
|---|---|
| Device Name | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides |
| Regulation | 21 CFR 862.1705 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
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 151)
Showing 20 most recent of 151 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150819 | Triglycerides | Randox Laboratories Limited | Aug 6, 2015 | SESE |
| K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | Siemens Healthcare Diagnostics, Inc. | Nov 22, 2013 | SESE |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | Ortho-Clinical Diagnostics, Inc. | May 31, 2013 | SESE |
| K113830 | VANTERA CLINICAL ANALYZER | Liposcience | Aug 30, 2012 | SESE |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | Seppim S.A.S. | May 19, 2011 | SESE |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Olympus America, Inc. | Mar 23, 2007 | SESE |
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE | Dade Behring, Inc. | Jan 18, 2005 | SESE |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Clinical Data, Inc. | Mar 10, 2004 | SESE |
| K020488 | CARESIDE TRGLYCERIDE | Careside, Inc. | Apr 15, 2002 | SESE |
| K010871 | TGL FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Jul 9, 2001 | SESE |
| K993466 | WAKO L-TYPE TRIGLYCERIDE TEST | Wako Chemicals USA, Inc. | Nov 9, 1999 | SESE |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | Carolina Liquid Chemistries Corp. | Jun 20, 1997 | SESE |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | Data Medical Associates, Inc. | May 29, 1997 | SESE |
| K964346 | PARAMAX TRIGLYCERID REAGENT | Dade Intl., Inc. | Mar 28, 1997 | SESE |
| K963424 | OLYMPUS LIPASE REAGENT | Olympus America, Inc. | Jan 14, 1997 | SESE |
| K961281 | TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 | Diagnostic Chemicals , Ltd. | Aug 16, 1996 | SESE |
| K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY | Trace America, Inc. | Aug 5, 1996 | SESE |
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | Horizon Diagnostics, Inc. | Jun 13, 1996 | SESE |
| K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY | Trace America, Inc. | Apr 5, 1996 | SESE |
| K960088 | TRUE TRIGLYCERIDE | Diagnostic Chemicals , Ltd. | Apr 1, 1996 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 13 clearances
- Boehringer Mannheim Corp. — 6 clearances
- Data Medical Associates, Inc. — 6 clearances
- Beckman Instruments, Inc. — 4 clearances
- Reagents Applications, Inc. — 4 clearances
