Rotem®
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative…
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. 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)).
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | TEM Innovations GmbH, Germany |
|---|---|
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K083842 |
| Record published | 2016-09-16 |
| Record revised | 2026-05-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| star-tem® 20 | 10 | In distribution | |
| delta System (US/CA) | In distribution | ||
| ROTROL P | 5 | In distribution | |
| in-tem® | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| George King Pooled Normal Plasma | George King BIO-Medical, Inc. | 15 |
| directCHECK Whole Blood Controls | Accriva Diagnostics, Inc. | 12 |
| Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 8 |
| Lyphochek | Bio-Rad Laboratories Inc. | 8 |
| George King Single Donor Normal Plasma | George King BIO-Medical, Inc. | 7 |
| Validate | LGC Clinical Diagnostics, Inc. | 6 |
| George King Coumadin® Plasma | George King BIO-Medical, Inc. | 5 |
| Plasma, Coagulation Control | Medtronic, Inc. | 5 |
| Liquichek | Bio-Rad Laboratories Inc. | 5 |
| CueSee® Coag | Eurotrol B.V. | 5 |
| CRYOcheck™ Pooled Normal Plasma | Precision BioLogic Inc. | 4 |
| i-STAT | Abbott Point OF Care Inc. | 4 |
Showing 12 of 129. All products under Plasma, Coagulation Control
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| TEM Systems Inc | 510(k) number | 2016-02-18 | Class II | Nonconforming Material/Component | 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. | 476 boxes x 5 vials | 2016-06-30 |
| TEM Systems Inc | 510(k) number | 2014-10-23 | Class II | Nonconforming Material/Component | Some of vials were found to be partially filled. | Total 1574 x 5 vials per box | 2015-08-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.