# K831478: Lyphochek Hemoglobin Aic Control Human

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 22, 1983 after 44 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021484: Hemoglobin A1C Control (2002), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K831478
Methodology: https://510kreport.com/methodology