# K021484: Hemoglobin A1C Control

- Pathway: 510(k) (Traditional)
- Applicant: Canterbury Scientific, Ltd.
- Decided: Jun 14, 2002 after 37 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831478 (1983). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831478: Lyphochek Hemoglobin Aic Control Human, Bio-Rad (1983) Summary page 1.

## Most influential descendants
- K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C (2012), 2 descendants of its own
- K133344: Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys Calibrators (2014), 1 descendant of its own
- K162281: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (2017), 0 descendants of its own
- K050100: RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ Analyzer (2005), 0 descendants of its own

## Recalls of this device
- Oct 5, 2018 · Class III · Z-0601-2019: Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and th

## Indications for use
The Hemoglobin A I c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbAl c quantitation.

Source page: https://510kreport.com/device/K021484
Methodology: https://510kreport.com/methodology