TEM Innovations EX-TEM, FIB-TEM, AP-TEM Assays

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR EUDAMED	Number4260160470020QR Basic UDI-DI 04260160470020UDI-DI	Date10 May 2026Registered	StatusActive
United States	GUDID listing GUDID	Number04260160470020 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK101533	Date10 Aug 2011Cleared	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK083842	Date23 Mar 2010Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 4260160470020QR — open Devices and search for it
AccessGUDID record UDI-DI 04260160470020
FDA 510(k) database 510(k) number K101533
FDA 510(k) database 510(k) number K083842

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 4260160470020QR registered 10 May 2026 Active
FDA 510(k) K101533 decided 10 Aug 2011 Active· +1 more in the status table
FDA GUDID UDI-DI 04260160470020 listed 16 Sep 2016 Listed

Recalls

6 recalls · FDA

3 recalls, same reason
- Terminated Z-2485-2019 FDA Class II initiated 23 Jul 2019
- Terminated Z-2487-2019 FDA Class II initiated 23 Jul 2019
- Terminated Z-2486-2019 FDA Class II initiated 23 Jul 2019
Prolonged clotting times
- Terminated Z-0302-2017 FDA Class II initiated 13 Sep 2016
Customers complained of low/empty reagent vials.
- Terminated Z-1090-2016 FDA Class II initiated 18 Feb 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.
- Terminated Z-1379-2015 FDA Class II initiated 23 Oct 2014
Some of vials were found to be partially filled.

Timeline

10 dated events

23 Mar 2010 Cleared FDA 510(k) K083842
10 Aug 2011 Cleared FDA 510(k) K101533
23 Oct 2014 Recall initiated FDA recalls Z-1379-2015
18 Feb 2016 Recall initiated FDA recalls Z-1090-2016
13 Sep 2016 Recall initiated FDA recalls Z-0302-2017
16 Sep 2016 Listed FDA GUDID 04260160470020
23 Jul 2019 Recall initiated FDA recalls Z-2485-2019
23 Jul 2019 Recall initiated FDA recalls Z-2487-2019
23 Jul 2019 Recall initiated FDA recalls Z-2486-2019
10 May 2026 Registered EUDAMED 4260160470020QR

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/IVDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name: ROTEM® delta EUDAMED
Rotem® GUDID
Generic name: Coagulation analyser IVD, laboratory, semi-automated
Model / Ref / Catalog: 200100 EUDAMED
delta System GUDID
200100-US GUDID

Primary DI / UDI-DI: 04260160470020
Basic UDI-DI: 4260160470020QR
510(k) Number: K101533 510(k)
K083842 GUDID
FDA product code: JPA, GGN
EMDN code: W0202029001 Thrombelastographs
GMDN term: Coagulation analyser IVD, laboratory, semi-automated

Device class: Class A EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 864.5425
EU registration type: Standard device
EU market of registration: Austria
Advisory committee: Hematology
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED 200100	510(k) —	GUDID delta System
510(k) Number	EUDAMED —	510(k) K101533	GUDID K083842
Device class	EUDAMED Class A	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Thrombelastograph Coagulation Analyzer Teg-5000 Series K002177 14 Sep 2000 FDA record

Cited by

QStat Cartridge K213917 29 Nov 2022 FDA record · FDA summary
ROTEM sigma Thromboelastometry System K201440 8 Jul 2022 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EX-TEM, FIB-TEM, and AP-TEM are diagnostic assays designed for in vitro coagulation studies using the ROTEM Delta Thromboelastometry System. These tests analyze clot formation, stability, and lysis in citrated whole blood samples, providing quantitative and qualitative insights into hemostatic function. The EX-TEM assesses intrinsic coagulation pathways, while the AP-TEM evaluates clot firmness under antifibrinolytic conditions, and the FIB-TEM specifically examines fibrinolysis dynamics.

These assays are supplied as single-use reagents for use with the ROTEM Delta System, a Class II medical device regulated under FDA 510(k) clearance (K101533) and IVDR compliance. They are intended for use in hematology laboratories and critical care settings, requiring no special storage conditions beyond refrigeration (2–8°C) and protection from light. The system and assays are MRI-unsafe due to electronic components and must be handled as in vitro diagnostics, adhering to manufacturer instructions for preparation and disposal.

Devices cleared under K101533

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K101533
		UDI-DI	Size and differences
ROTEM® ap-tem® Tem Innovations GmbH	503-04-US / ap-tem®	04260160470068	—	On the market
ROTEM® ex-tem® Tem Innovations GmbH	503-05-US / ex-tem®	04260160470242	—	On the market
ROTEM® fib-tem® Tem Innovations GmbH	503-06-US / fib-tem®	04260160470075	—	On the market

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Properties

Near-patient testing
Professional testing
IVD instrument
Serial number
Manufacturing date

Other properties (21, all answered No)