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Extendsure Hbfasc Control

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053031

by Cantebury Scientific , Ltd.

Identifiers

510(k) Number
K053031 FDA 510(k)
FDA Product Code
JCM FDA 510(k)

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)

EXTENDSURE HBFASC CONTROL is a hemoglobin abnormal control used in hematology to monitor the performance of hemoglobin variant testing assays. It is designed to control setpoints in monitoring for Hb variant testing across methodologies such as ion-exchange HPLC, isoelectric focusing (IEF), and gel and capillary electrophoresis. The device is classified under product code JCM and regulation number 864.7415, and is associated with hematology as its medical specialty.

The device is supplied as a lyophilized control kit containing vials of stabilized hemolysate prepared from human blood. It is intended for use in clinical laboratories performing hemoglobinopathy testing and is regulated under FDA 510(k) authorization with decision code SESE and substantial equivalence determination. The product is manufactured by Cantebury Scientific, Ltd., located in Christchurch, Canterbury, New Zealand, and is subject to standard storage and handling procedures for lyophilized in vitro diagnostic controls.

Frequently asked questions

What is the EXTENDSURE HBFASC CONTROL used for?

EXTENDSURE HBFASC CONTROL is a hemoglobin abnormal control used to monitor the performance of hemoglobin variant testing assays in clinical laboratories. It ensures accuracy and consistency in detecting Hb variants across methodologies such as ion-exchange HPLC, isoelectric focusing, and gel or capillary electrophoresis by providing stable setpoints for quality control.

How is the EXTENDSURE HBFASC CONTROL supplied and stored?

The device is supplied as a lyophilized control kit containing vials of stabilized hemolysate prepared from human blood. It requires standard storage and handling procedures for lyophilized in vitro diagnostic controls, typically involving refrigeration before reconstitution and controlled conditions after opening, as per manufacturer guidelines for stability and integrity.

Is the EXTENDSURE HBFASC CONTROL for single-use or reuse?

EXTENDSURE HBFASC CONTROL is intended for single-use per testing run, as it is a lyophilized control designed to be reconstituted and used immediately to monitor assay performance. Reuse is not recommended due to potential degradation of the stabilized hemolysate and risk of contamination, which could compromise control reliability and test accuracy.

What regulatory pathway was used for the EXTENDSURE HBFASC CONTROL?

EXTENDSURE HBFASC CONTROL received FDA 510(k) authorization under decision code SESE, indicating a substantial equivalence determination. It was cleared via a traditional 510(k) submission, with the device classified under product code JCM and regulation number 864.7415 for hemoglobin abnormal controls in hematology.

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: Canterbury Scientific Ltd | Hemoglobin Controls | Home, HbFASC/A2 controls - CANTERBURY SCIENTIFIC, EXTENDSURE HBFASC CONTROL (K053031) — FDA 510(k) | Innolitics, ExtendSURE HB610 The lyophilised Hemoglobin FASC… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cantebury Scientific , Ltd.

Sources (1)

  • FDA 510(k) K053031 24 fields · synced Sep 24, 2026