Lead Test System

Published On -

I3CGlobal FDA 510k, IVDR

FDA 510K for Lead Test System

A Lead Test System refers to an In Vitro Diagnostic (IVD) medical device intended to measure the level of lead in human blood, allowing for the diagnosis of lead poisoning by analyzing the sample outside of the body. Most lead test systems use an electrochemical technique, such as anodic stripping voltammetry (ASV), to detect lead in a sample.

Intended Use of Lead Test System

A Lead Test System is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

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 Lead Test System  
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FDA 510K for Lead Test System Device Code and Regulation Number

S.NO Product code Device Regulation Description Regulation Name Device Class

1.

DOF

 Lead, Atomic Absorption Lead Test System

862.3550

2

Anti-Mullerian Hormone Test System (AMH)

Intended Use: The Lead Testing System is designed to quantitatively measure the amount of lead in a whole blood sample. The Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use only with the Lead Testing System. This test system is for prescription use only. This system is not intended for point of care use.

Device Description

The Lead Testing System is a six-channel analyzer to quantitatively measure the amount of lead in a whole blood sample. It uses the same test kit components, including sensors, control materials, and reagent tubes.

This device measures lead in blood using Anodic Stripping Voltammetry (ASV). It runs on AC power or batteries with an LCD screen, sensor connector, and calibration button. The screen shows instructions, results, lot codes, and error messages, while the calibration button loads test parameters.

To test for lead, a blood sample is mixed in a reagent tube, breaking red blood cells to release lead. The mixture is applied to the sensor, where the analyzer applies an electrical charge to collect and then release the lead, generating a measurable current. The lead level is then displayed in micrograms per deciliter (µg/dL).

Performance Testing (Analytical) for Lead Test System

    • Precision/ Reproducibility
    • Linearity/assay reportable range
    • Traceability, Stability, Expected values (controls, calibrators, or methods)
    • Limit of blank
    • Limit of Detection (LOD)
    • Limit of Quantification (LOQ)
    • Analytical Specificity
    • Expected values/ Reference range
    • Method and matrix comparison

Clinical Testing:

No Guidance available for 510k submission

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