# K201440: ROTEM sigma Thromboelastometry System

- Pathway: 510(k) (Traditional)
- Applicant: Tem Innovations GmbH
- Decided: Jul 8, 2022 after 767 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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 K002177 (2000). 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)
- K083842: Rotem Delta Thromboelastometry System, Pentapharm GmbH (2010) Summary page 4.
- K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System, Tem Innovations GmbH (2011) Summary page 4.

## Indications for use
The ROTEM sigma thromboelastometry system is a fully integrated and automated in vitro diagnostic system designed to monitor and analyze a patient's coagulation status by measuring the viscoelastic properties of a 3.2% citrated venous or arterial whole blood sample. The ROTEM sigma system is indicated for use with adult patients 21 years and older where a semi-quantitative evaluation of their blood coagulation properties is desired, in the point of care and laboratory settings. Coagulation evaluations on the ROTEM sigma instrument, together with the ROTEM sigma complete + hep cartridge, are used to assess peri-operative hemorrhage and/or thrombosis in cardiovascular surgery and liver transplantation. The single use, multichannel cartridge ROTEM sigma complete + hep contains the following assays: INTEM C is a semi-quantitative assay used to monitor coagulation via the intrinsic pathway in citrated whole blood samples. EXTEM C is a semi-quantitative assay used to monitor coagulation via the extrinsic pathway in citrated whole blood samples. FIBTEM C is a semi-quantitative assay used to monitor coagulation via the extrinsic pathway in citrated whole blood samples, after blocking platelet contribution to clot firmness. HEPTEM C is a sem i-quantitative assay used to monitor coagulation via the intrinsic pathway in citrated whole blood samples, after inactivating heparin. Results from the ROTEM sigma should not be the sole basis for a patient diagnosis; ROTEM sigma results should be considered along with a clinical assessment of the patient's condition and other laboratory tests. For in vitro Diagnostic Use. For professional use only.

Source page: https://510kreport.com/device/K201440
Methodology: https://510kreport.com/methodology