# K070546: Lyphochek Diabetes Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Apr 2, 2007 after 35 days
- Product code: GGM (Control, Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K862186 (1986). 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)
- K862186: Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II, Bio-Rad (1986) Summary page 1.

## Indications for use
Lyphochek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K070546
Methodology: https://510kreport.com/methodology