Low Density Lipoprotein (LDL) Immunological Test System

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I3CGlobal FDA 510k, IVDR

FDA 510K for Low Density Lipoprotein (LDL) Immunological Test System

A Low-Density Lipoprotein (LDL) Immunological Test System is a diagnostic system used to quantify LDL cholesterol levels in blood samples. This test helps assess cardiovascular disease (CVD) risk, including conditions like atherosclerosis, coronary artery disease (CAD), and hyperlipidemia.

Intended use of Low-Density Lipoprotein (LDL) Immunological Test System

A Low-Density Lipoprotein Immunological Test System is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Low Density Lipoprotein (LDL) Immunological Test System
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FDA 510K for Direct to Consumer Access Pharmacogenetic Assessment System Device Code and Regulation Number

S.

No

 Product

 Code

 Device Regulation Number Device Class

1.

DFC
Lipoprotein, Low-Density, Antigen, Antiserum, Control
866.5600

2

Lipoprotein, Low-Density, Antigen, Antiserum, Control

Intended use.

It is an in vitro diagnostic Immunological Test System intended for the quantitative determination of low-density lipoprotein (Lp(a)) concentrations in human serum or plasma. The measurement of Lp(a) is intended to be used as an aid in evaluating lipid metabolism disorders and assessing the risk of atherosclerotic cardiovascular disease in specific patient populations. Results are intended to be used in conjunction with clinical evaluation and other laboratory findings to support patient risk assessment and management decision.

Device Description

Device consists of immunological reagents and controls designed to quantitatively measure low-density lipoprotein (Lp(a)) in human serum or plasma samples using an immunoassay methodology (commonly immunoturbidimetric or latex-enhanced immunoassay) performed on automated clinical chemistry analysers.

Key Components

  • Assay Reagents
  • Antigen/Antiserum Reaction System
  • Calibrators and Controls
  • Buffers and Diluent Solutions

Performance testing (analytical-Nonclinical) for Low-Density Lipoprotein (LDL) Immunological Test System

  • Precision/Reproducibility
  • Linearity
  • Limit of Blank (LOB) / Limit of Detection (LOD) / Limit of Quantitation (LOQ)
  • Analytical sensitivity
  • Analytical specificity
  • Interference
  • Assay reportable range
  • Dilution
  • High dose hook effect
  • Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
  • Detection limit
  • Assay cut-off
  • Method comparison
  • Matrix comparison

Clinical studies

No Guidance available  for 510k submission

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