# K053031: Extendsure Hbfasc Control

- Pathway: 510(k) (Traditional)
- Applicant: Cantebury Scientific, Ltd.
- Decided: Dec 7, 2005 after 41 days
- Product code: JCM (Control, Hemoglobin, Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.7415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933086 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933086: Afsc Hemo Control #5331, AA2 Hemo Control #5328, Helena Laboratories (1994) Summary page 1.
- K011389: Hemoglobin F & A2 Control (Beta-Thalassaemia Control), Canterbury Health Laboratories (2001) Summary page 1.

## Indications for use
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary electrophoresis, cellulose acetate and agar/agarose gel electrophoresis. The Hemoglobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization. The control is for in vitro diagnostic use only and should not be used past the expiry date.

Source page: https://510kreport.com/device/K053031
Methodology: https://510kreport.com/methodology