# K071648: Extendsure Lyophilized HBA1C Linearity Controls

- Pathway: 510(k) (Traditional)
- Applicant: Canterbury Scientific, Ltd.
- Decided: Aug 22, 2007 after 65 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 K003030 (2000). 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)
- K003030: Lyphochek Hemoglobin Alc Linearity Set, Bio-Rad (2000) Summary page 1.

## Indications for use
For in vitro diagnostic use only. The extendSURETM lyophilized hemoglobin Alc linearity controls are intended to verify the linearity of HbAlc assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.

Source page: https://510kreport.com/device/K071648
Methodology: https://510kreport.com/methodology