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E-Z Chek Blood Leak Test Strips

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123805

by Reprocessing Products Corp

Identifiers

510(k) Number
K123805 FDA 510(k)
FDA Product Code
FJD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The E-Z Chek Blood Leak Test Strips are a diagnostic detector designed to identify the presence of blood in dialysate during hemodialysis procedures. Classified as a blood leak detector, these strips are intended to differentiate between actual membrane leaks and false machine alarms in dialysis systems. Their primary function is to enhance patient safety by confirming or ruling out blood contamination in the dialysate, ensuring accurate detection even in the presence of typical dialysis solution components. This aids clinicians in making informed decisions regarding dialyzer integrity and patient care.

These test strips are supplied in packs of 25 and are intended for single-use in clinical hemodialysis settings. They are not sterile but are designed for immediate use upon opening, with no specific regulatory requirements for sterilisation stated. The strips are compatible with standard hemodialysis equipment and are intended for use in environments where blood leak detection is critical, such as dialysis units. Authorised under FDA 510(k) clearance (K123805), they fall under device classification II and are regulated under the FDA’s medical specialty categories for gastroenterology and urology, specifically for leak detection in dialysis systems.

Frequently asked questions

What is the primary purpose of the E-Z Chek Blood Leak Test Strips?

The E-Z Chek Blood Leak Test Strips are designed to identify the presence of blood in the dialysate during hemodialysis. Their key function is to differentiate between actual membrane leaks and false alarms from dialysis machines, ensuring clinicians can confirm or rule out blood contamination. This helps maintain patient safety by validating dialyzer integrity and preventing unnecessary interventions.

How are the E-Z Chek Blood Leak Test Strips supplied, and are they sterile?

These strips are supplied in packs of 25 and are intended for single-use in clinical hemodialysis settings. They are not sterile, but they are packaged for immediate use upon opening without requiring additional sterilization procedures. The manufacturer does not specify regulatory sterilization requirements, so they should be handled in a manner consistent with single-use diagnostic devices.

Can these strips be reused, or are they intended for one-time use?

The E-Z Chek Blood Leak Test Strips are explicitly designed for single-use only. Reusing them could compromise accuracy and patient safety, as the strips may degrade or become contaminated after one application. Always use a fresh strip for each test to ensure reliable detection of blood leaks in the dialysate.

Are these strips compatible with all hemodialysis equipment?

The E-Z Chek Blood Leak Test Strips are compatible with standard hemodialysis equipment, as specified by the manufacturer. However, compatibility may depend on the specific dialysis system’s design and how the strips are integrated into the testing protocol. Always verify with your equipment manufacturer if there are any system-specific requirements for use.

What regulatory pathway does the E-Z Chek Blood Leak Test Strips follow?

The E-Z Chek Blood Leak Test Strips are authorized under the FDA 510(k) clearance process, specifically under clearance number K123805. They fall under Class II medical devices and are regulated under the FDA’s medical specialty categories for gastroenterology and urology, particularly for leak detection in dialysis systems. This classification ensures they meet stringent performance and safety standards for diagnostic use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K100-0114 - RPC Rabrenco, PDF E-Z Chek® Blood Leak Test Strips - rpc-rabrenco.com, Rpc EZ CHEK BLOOD LEAK TEST 25/BTL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Reprocessing Products Corp

Sources (1)

  • FDA 510(k) K123805 24 fields · synced Oct 1, 2026