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K Number
K971640
Device Name
LEADCARE BLOOD LEAD TESTING SYSTEM
Manufacturer
ESA, INC.
Date Cleared
1997-09-09

(130 days)

Product Code
DOF
Regulation Number
862.3550
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The LEADCARE System is suitable for use in a physician office laboratory environment (POL).

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a blood lead testing system. It acknowledges the device's substantial equivalence to previously marketed devices but does not contain any information regarding acceptance criteria, study details, or performance data.

Therefore, I cannot answer your request based on the provided input. The document is a regulatory approval notice, not a technical study report.

§ 862.3550 Lead test system.

(a)
Identification. 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.(b)
Classification. Class II.