CHH · Enzymatic Esterase--Oxidase, Cholesterol
Clinical Chemistry · 21 CFR 862.1175 · Class 1
Overview
| Product Code | CHH |
|---|---|
| Device Name | Enzymatic Esterase--Oxidase, Cholesterol |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism 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 230)
Showing 20 most recent of 230 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251091 | Lipids | Truvian Health | Dec 30, 2025 | SESE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | Aug 9, 2024 | SESE |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | Jun 30, 2022 | SESE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | Mar 27, 2019 | SESE |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | Oct 18, 2018 | SESE |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | Mar 28, 2018 | SESE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | Jul 11, 2017 | SESE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | Polymer Technology Systems, Inc. | Dec 22, 2016 | SESE |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | Sep 29, 2015 | SESE |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | Mar 21, 2014 | SESE |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | Abaxis, Inc. | Feb 15, 2013 | SESE |
| K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Oct 5, 2012 | SESE |
| K120202 | EON CHOLESTEROL REAGENT | Vital Diagnostics Pty., Ltd. | Jul 27, 2012 | SESE |
| K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Jul 3, 2012 | SESE |
| K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Mar 29, 2012 | SESE |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | Hitachi Chemical Diagnostics, Inc. | Dec 14, 2011 | SESE |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | Alfa Wassermann, Inc. | Oct 26, 2009 | SESE |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | Jas Diagnostics, Inc. | Nov 17, 2008 | SESE |
| K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | Medica Corp. | Feb 20, 2008 | SESE |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Polymer Technology Systems, Inc. | Oct 15, 2007 | SESE |
Top Applicants
- Cholestech Corp. — 10 clearances
- Em Diagnostic Systems, Inc. — 10 clearances
- Beckman Instruments, Inc. — 7 clearances
- Boehringer Mannheim Corp. — 7 clearances
- Polymer Technology Systems, Inc. — 7 clearances
