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Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K050709

by Wallac Oy

Identifiers

510(k) Number
K050709 FDA 510(k)
FDA Product Code
GKA FDA 510(k)
Models / Variants
Fr-9120 FDA 510(k)EUDAMED
Fr-9400 FDA 510(k)EUDAMED
Fr-9360 FDA 510(k)EUDAMED
Fr-9367 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7415 FDA 510(k)
Regulation Number
864.7415 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Abnormal Hemoglobin Quantitation system, classified under the nomenclature for hematology diagnostics. It quantifies abnormal hemoglobin variants in blood samples using a JB-2 staining method, enabling precise identification and measurement of hemoglobinopathies such as sickle cell disease or thalassemia.

The Resolve Hemoglobin Kit is supplied as a reagent-based system for in vitro diagnostic use, intended for laboratory settings. Models FR-9120, FR-9400, FR-9360, and FR-9367 are designed for single-use and comply with FDA 510(k) clearance, IVD Directive (IVDD), and IVD Regulation (IVDR) requirements. Storage conditions and MRI safety are not specified, but the system requires adherence to standard laboratory protocols for reagent handling and sample processing.

Frequently asked questions

What clinical conditions can the Resolve Hemoglobin Kit help identify and measure using the JB-2 staining method?

The Resolve Hemoglobin Kit is designed to quantify abnormal hemoglobin variants in blood samples, which helps in the precise identification and measurement of hemoglobinopathies such as sickle cell disease and thalassemia. By using the JB-2 staining method, it enables laboratories to detect and analyze these conditions for diagnostic purposes.

Are the models FR-9120, FR-9400, FR-9360, and FR-9367 intended for single-use or repeated use?

The Resolve Hemoglobin Kit models FR-9120, FR-9400, FR-9360, and FR-9367 are explicitly designed for single-use only. This is a standard practice for reagent-based diagnostic systems to ensure accuracy, sterility, and patient safety in laboratory settings.

What regulatory pathways has the Resolve Hemoglobin Kit followed for approval, and which organizations have cleared or authorized its use?

The kit has undergone FDA 510(k) clearance, the In Vitro Diagnostic Device Directive (IVDD), and compliance with the In Vitro Diagnostic Regulation (IVDR). These pathways confirm its adherence to safety, performance, and regulatory standards for in vitro diagnostic use in the U.S. and EU markets.

How should the Resolve Hemoglobin Kit be stored, and are there any special handling instructions for the reagents?

While specific storage conditions (e.g., temperature, light exposure) aren’t detailed in the provided data, the kit requires adherence to standard laboratory protocols for reagent handling and sample processing. Always follow the manufacturer’s instructions included with the kit to maintain reagent integrity and ensure accurate diagnostic results.

What types of laboratories are the Resolve Hemoglobin Kit models intended for, and what is the primary use case?

The kit is intended for laboratory settings specializing in hematology diagnostics. Its primary use case is quantifying abnormal hemoglobin variants in blood samples, which aids in diagnosing and monitoring hemoglobinopathies like sickle cell disease and thalassemia. It is not intended for point-of-care or non-laboratory 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wallac Oy

Sources (2)

  • FDA 510(k) K050709 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026