# K183160: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corporation
- Decided: May 9, 2019 after 175 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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: 2 generations back to K954137 (1995). 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)
- K993678: Thrombelastograph Coagulation Analyzer Teg - 5000 Series, Haemoscope Corp. (2000) Summary page 5.
- K002177: Thrombelastograph Coagulation Analyzer Teg-5000 Series, Haemoscope Corp. (2000) Summary page 5.

## Recalls of this device
- Apr 20, 2020 · Class II · Z-2061-2020: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

## Indications for use
The TEG® 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and TEG 6s Citrated: K, RT, FF Assay Cartridge. The TEG® 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The TEG® 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots. The Citrated: K, RT, FF Assay Cartridge contains three independent assays (CK, CRT and CFF) and the system output consists of a table of numerical values for parameters R, LY30, and MA. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and LY30 (fibrinolysis after 30 minutes of reaching maximum clot strength). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. Clotting characteristics are described by the functional parameter MA (maximum clot strength). The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG® 6s Hemostasis System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameter MA (maximum clot strength). Results from the TEG® 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. The indication for TEG® 6s Hemostasis System use is with adult patients (18 years and older) where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the TEG® 6s Hemostasis System using the Citrated: K, RT, FF Assay Cartridge is used to assess clinical conditions in a trauma setting to assess hemorrhage or thrombosis conditions. For professional use only.

Source page: https://510kreport.com/device/K183160
Methodology: https://510kreport.com/methodology