# K040275: Lyphochek Hemostasis Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Feb 27, 2004 after 22 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941737 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020878: Lyphochek Hemostasis, Models 798, 799, Bio-Rad (2002) Summary page 1.

## Indications for use
For use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. Analytes listed in the package insert: Antithrombin III (AT III) Activated Partial Thromboplastin Time (APTI) D-dimer Factor II Factor V Factor VIII Factor VIII Factor IX Factor Xi Factor XII Fibrinogen Plasminogen Protein C (Functional) Protein S (Functional) Prothrombin Time (PT) Thrombin Time (TT)

Source page: https://510kreport.com/device/K040275
Methodology: https://510kreport.com/methodology