# K083842: Rotem Delta Thromboelastometry System

- Pathway: 510(k) (Traditional)
- Applicant: Pentapharm GmbH
- Decided: Mar 23, 2010 after 454 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002177 (2000). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002177: Thrombelastograph Coagulation Analyzer Teg-5000 Series, Haemoscope Corp. (2000) Summary page 1.

## Most influential descendants
- K213917: QStat Cartridge (2022), 4 descendants of its own
- K240045: QStat Cartridge (2024), 1 descendant of its own
- K230461: Quantra Hemostasis Analyzer (2023), 1 descendant of its own
- K251404: Quantra QStat Cartridge (2025), 0 descendants of its own
- K232215: Quantra Hemostasis Analyzer (2023), 0 descendants of its own

## Recalls of this device
- Feb 18, 2016 · Class II · Z-1090-2016: Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.
- Oct 23, 2014 · Class II · Z-1379-2015: Some of vials were found to be partially filled.

## Indications for use
The ROTEM® delta is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis. ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. The in-TEM® assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis. The hep-TEM® assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process, via the intrinsic pathway in the presence of unfractionated heparin, in citrated whole blood specimens. The hep-TEM® reagent is used to inactivate heparin in patients receiving unfractionated heparin. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis. The NATEM assay is a semi-quantitative in vitro diagnostic assay used on the ROTEM® delta Thromboelastometry System to monitor the coagulation process, contact-activated by the surface of the measurement cell, in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis. The star-TEM® Reagent is intended for use as a recalcification reagent in the NATEM and INTEM assays on the ROTEM® delta Thromboelastometry System. The indication for ROTEM® delta use is with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and/or thrombosis.

Source page: https://510kreport.com/device/K083842
Methodology: https://510kreport.com/methodology