Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Device Facts
| Record ID | K241800 |
|---|---|
| Device Name | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | MRR · Clinical Chemistry |
| Decision Date | Jul 26, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
Indications for Use
Atellica® CH HDL Cholesterol (HDLC) assay The Atellica® CH HDL Cholesterol (HDLC) assay is for in vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) using the Atellica® CH Analyzer. HDLC measurements are used in the diagnosis and treatment of atherosclerosis. Atellica® CH LDL Cholesterol (LDLC) assay The Atellica® CH LDL Cholesterol (LDLC) assay is for in vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin) using the Atellica® CH Analyzer. LDLC measurements are used in the diagnosis and treatment of atherosclerosis.
Device Story
Atellica CH HDL and LDL assays are in vitro diagnostic reagents for use on the Atellica CH Analyzer. The HDLC assay uses an accelerator selective detergent method; non-HDL cholesterol is consumed by an enzyme reaction; a second reagent solubilizes HDL for colorimetric measurement. The LDLC assay is a homogeneous assay; detergent 1 solubilizes non-LDL particles for enzymatic consumption; detergent 2 solubilizes LDL particles for colorimetric measurement via peroxidase reaction with DSBmT and 4-aminoantipyrine. Output is a quantitative cholesterol concentration (mg/dL) measured via bichromatic endpoint technique. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing and managing atherosclerosis and lipid disorders. Benefits include direct measurement without off-line pretreatment or centrifugation.
Clinical Evidence
Bench testing only. Studies performed per CLSI guidelines (EP05-A3, EP07-ED3, EP09C-ED3, EP17-A2). Precision (repeatability/within-lab CVs < 3%), linearity, and interference (HIL) verified. Method comparison against predicate devices showed high correlation (r ≥ 0.996). No clinical prospective/retrospective studies conducted.
Technological Characteristics
Two-reagent enzymatic colorimetric assays. HDLC uses accelerator selective detergent; LDLC uses two-detergent system. Measurement via bichromatic endpoint (545/694 nm). Standardized to NCEP reference methods. Compatible with serum, lithium heparin, sodium heparin, and EDTA plasma. Software-controlled analysis on Atellica CH Analyzer.
Indications for Use
Indicated for quantitative determination of HDL and LDL cholesterol in human serum and plasma to aid in the diagnosis and treatment of atherosclerosis in adult populations.
Regulatory Classification
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.
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