# K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System

- Pathway: 510(k) (Traditional)
- Applicant: Tem Innovations GmbH
- Decided: Aug 10, 2011 after 433 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 5 (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
- Jul 23, 2019 · Class II · Z-2485-2019: Prolonged clotting times
- Jul 23, 2019 · Class II · Z-2487-2019: Prolonged clotting times
- Jul 23, 2019 · Class II · Z-2486-2019: Prolonged clotting times
- Sep 13, 2016 · Class II · Z-0302-2017: Customers complained of low/empty reagent vials.
- Oct 23, 2014 · Class II · Z-1379-2015: Some of vials were found to be partially filled.

## Indications for use
The EXTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM8 delta Thromboelastometry System to monitor the coagulation process via the extrinsic 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)). Speed of clot formation time (OFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system 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 FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking platelet contribution to the clot firmness The fib-TEM® reagent is always used in conjunction with ex-TEM® reagent. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system 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 APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM®D delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. The ap-TEM® reagent is always used in conjunction with ex-TEM® reagent. 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)). Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system 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/K101533
Methodology: https://510kreport.com/methodology