LeadCare II Blood Lead Analyzer 70-6760 Point-of-Care Testing System (RX)

Magellan LeadCare II Blood Lead Analyzer 70-6760 – CLIA-Waived Point-of-Care System

The LeadCare II Blood Lead Analyzer 70-6760 is a compact, portable point-of-care system designed for quantitative blood lead testing in qualified healthcare settings.

This product is restricted to qualified healthcare professionals/facilities. Orders cannot be shipped until the required authorization documentation has been received and approved. Click Here to download and complete our Prescription Drug / Device Authorization Form.

LeadCare II provides blood lead results in approximately 3 minutes using a small 50 µL whole-blood sample. The system is CLIA waived when used according to the manufacturer's instructions, making it well suited for physician offices, pediatric practices, community health programs and other appropriate point-of-care testing environments.

With a lightweight 2.4 lb analyzer, battery or AC operation and electronic calibration, LeadCare II provides a convenient alternative to sending every blood lead sample through a traditional laboratory workflow.

Manufacturer Part Number: 70-6760

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Important: A LeadCare II Blood Lead Test Kit 70-6762 is required to perform testing and is sold separately.

Add a LeadCare II Test Kit and Start Testing

A LeadCare II Blood Lead Test Kit 70-6762 is required to operate the analyzer.

Each test kit contains the materials required to perform 48 blood lead tests, including compatible sensors, treatment reagent, capillary collection components, transfer droppers, quality controls and an electronic calibration button.

Buying a new analyzer? Add a 48-test LeadCare II Test Kit to your order so your facility has the testing supplies required to begin using the system.

Why Choose the LeadCare II Blood Lead Analyzer?

LeadCare II is designed to simplify point-of-care blood lead testing with a compact analyzer and dedicated disposable testing supplies.

Key features include:

• Results in approximately 3 minutes
• Requires only a 50 µL whole-blood sample
• CLIA-waived testing system
• Reportable range of 3.3–65 µg/dL
• Electrochemical testing method
• Disposable test sensors
• Electronic calibration
• Two levels of quality control supplied with the test kit
• Compact 9" × 6.5" × 3.5" analyzer
• Lightweight at approximately 2.4 lb
• Operates using AC power or batteries
• FDA 510(k) K052549

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These specifications are published by the manufacturer for the LeadCare II system.

Point-of-Care Blood Lead Results in Approximately 3 Minutes

LeadCare II is designed to provide a quantitative blood lead result in approximately three minutes.

Point-of-care testing allows qualified healthcare professionals to perform the test within the clinical environment rather than relying exclusively on an outside laboratory workflow.

The analyzer uses an electrochemical testing method with disposable sensors and provides a reportable blood lead range of 3.3 to 65 µg/dL.

Small 50 µL Whole-Blood Sample

The LeadCare II system requires approximately 50 µL of whole blood for testing.

For capillary collection, healthcare professionals should use the collection components supplied with the compatible LeadCare II Blood Lead Test Kit and follow the manufacturer's current Instructions for Use.

Portable Blood Lead Testing System

At approximately 2.4 pounds, LeadCare II is compact enough for point-of-care environments where portability and counter space are important.

The analyzer measures approximately:

9" wide × 6.5" deep × 3.5" high

It can operate using either four 1.5V alkaline or lithium batteries or AC power, giving healthcare facilities flexibility in where the analyzer is used.

Electronic Calibration & Quality Control

LeadCare II uses an electronic calibration button, eliminating the need for a traditional manual calibration procedure.

Compatible LeadCare II test kits also include two levels of room-temperature-stable quality control material.

Healthcare professionals should follow the current manufacturer instructions for calibration, quality control, sample collection and testing.

LeadCare II 70-6760 Specifications

What's Included with the LeadCare II Analyzer 70-6760?

The LeadCare II Analyzer Kit includes:

• LeadCare II Blood Lead Analyzer
• AC power cord
• AA batteries
• Quick Reference Guide
• LeadCare II User's Guide
• Training/instructional resources

The manufacturer's current parts and service documentation identifies these components as part of analyzer kit 70-6760.

Test Kit Sold Separately

The LeadCare II 70-6760 Analyzer does not include the consumable test kit required to perform blood lead tests.

Order the LeadCare II Blood Lead Test Kit 70-6762 separately or select the test-kit option when ordering your analyzer.

LeadCare II Analyzer + 70-6762 Test Kit

The LeadCare II system consists of two primary components:

The manufacturer states that all that is needed to get started is the analyzer and a compatible test kit.

Who Is the LeadCare II Analyzer Designed For?

LeadCare II may be appropriate for qualified healthcare organizations performing point-of-care blood lead testing, including:

• Pediatric practices
• Primary care practices
• Community health centers
• Public health programs
• Physician office laboratories
• Occupational health programs
• Other qualified point-of-care testing environments

Facilities should follow the manufacturer's current Instructions for Use and applicable federal, state and local requirements when establishing a blood lead testing program.

Important LeadCare II Sample Collection Information

For capillary blood collection, use only the capillary collection devices validated and supplied for use with the LeadCare II Blood Lead Test Kit.

Healthcare professionals should follow the current LeadCare II Instructions for Use for sample collection, preparation, quality control and testing.

Why Buy the LeadCare II Analyzer from Mohawk Medical Mall?

Mohawk Medical Mall is backed by Mohawk Healthcare, a medical supply and equipment distributor serving healthcare organizations since 1946.

When purchasing a LeadCare II Blood Lead Analyzer, customers can count on:

• Genuine professional diagnostic equipment
• Compatible LeadCare II Test Kits available
• Convenient analyzer + test kit ordering
• Knowledgeable medical supply support
• Secure online ordering
• Nationwide shipping
• Decades of experience serving healthcare providers

Learn More About the LeadCare II Blood Lead Testing System

New to LeadCare II or considering point-of-care blood lead testing for your practice? Read our Complete Guide to the LeadCare II Blood Lead Analyzer to learn how the LeadCare II system works, including sample requirements, approximately 3-minute testing, CLIA-waived operation, reportable range, test kit requirements, quality controls, and answers to frequently asked questions. Whether you're purchasing a new LeadCare II Analyzer or replenishing LeadCare II Blood Lead Test Kits, our guide can help you better understand the system and the supplies needed for blood lead testing.