# K043070: Liquid Stable HBA1C Control

- Pathway: 510(k) (Traditional)
- Applicant: Canterbury Scientific, Ltd.
- Decided: Dec 9, 2004 after 31 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K032791 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032791: Glycohemosure HBA1C Control, Quantimetrix Corp. (2003) Summary page 1.

## Indications for use
The Liquid Stable Hemoglobin Alc Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbAlc quantitation. The control is designed for use with Ion exchange HPLC assays, Immunoassay based analyses and Boronate Affinity based assays. The use of quality control materials is indicated as an objective assessment of the precision and bias of methods and techniques in use and is an integral part of good laboratory practices. The two levels of controls allow performance monitoring within the clinical range. The controls are for in vitro diagnostic use only and should not be used past the expiry date.

Source page: https://510kreport.com/device/K043070
Methodology: https://510kreport.com/methodology