(454 days)
Not Found
No
The description focuses on the mechanical and optical detection of clot formation and the calculation of predefined numerical parameters based on the resulting curve. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) instrument used to analyze the coagulation state of blood samples, assisting in the assessment of patient clinical hemostasis conditions. It does not directly treat or prevent a disease or condition in a patient, which is characteristic of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states "The ROTEM® delta Thromboelastometry System is designed for invitro diagnostic use by professionals in a laboratory environment." and "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."
No
The device description explicitly states that the system consists of a four-column instrument, reagents, quality controls, and measurement cells, in addition to software. This indicates significant hardware components are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The ROTEM® delta Thromboelastometry System is designed for invitro diagnostic use by professionals in a laboratory environment."
- Purpose: The system is intended to "provide a qualitative and quantitative indication of the coagulation state of a blood sample." This is a diagnostic purpose performed on a biological sample outside of the body.
- Analysis of Biological Sample: The device analyzes "citrated whole blood" samples.
- Diagnostic Output: The output includes "qualitative graphical representation" and "numerical parameters describing the curve quantitatively," which are used to assess the coagulation state.
- Use of Reagents: The system uses "specific blood modifiers (so-called reagents)" which are common components of IVD systems used to interact with the sample.
- Quality Control Materials: The mention of "quality control material for monitoring accuracy and precision of tests" (ROTROL N and ROTROL P) is typical for IVD devices to ensure reliable results.
- Specific Assays: The description of specific assays like in-TEM®, hep-TEM®, and NATEM, which are described as "semi-quantitative in vitro diagnostic assay," further confirms the IVD nature.
- Clinical Context: While the results are not the sole basis for diagnosis, they are intended to "assist in the assessment of patient clinical hemostasis conditions" and are used in clinical settings like "organ transplantation, cardiovascular surgery, cardiology procedures and trauma."
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ROTEM® delta Thromboelastometry System is designed for invitro diagnostic use by professionals in a laboratory environment. The ROTEM® system 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® system records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and Ivses 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 ROTEM® system provides specific blood modifiers (so-called reagents) intended to be used with the system, as additive to the blood sample.
The results of the ROTEM® analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history (anamnesis), the clinical picture and, if necessary, further coagulations tests.
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. Coagulations 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. Coagulations 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. Coagulations 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. Coagulations 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.
Product codes
JPA, GGN
Device Description
The ROTEM® delta Thromboelastometry System consists of a fourcolumn instrument (with integrated computer module, computer controlled electronic pipette, software), system reagents (in-TEM® hep-TEM®, star-TEM®), quality controls (ROTROL N, ROTROL P) and measurement cells (Cup and Pin pro). The blood sample is filled into a cylindrical cup. A pin oscillates permanently while it is immersed in the blood holding cup. The motion of the pin is detected by an optical detection system. Data are processed and analyzed by a computer with special software. If no clotting takes place, the movement of the pin is not obstructed. When a clot forms and attaches itself to the pin and cup surfaces, the movement is obstructed. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into an amplitude with the following definitions applying to the thromboelastogram (TEM): An amplitude of 0 mm means unobstructed rotation, while an amplitude of 100mm can be regarded as infinite firmness and blocking of the pin by the clot. The TEM amplitude is a measure of the clot firmness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
professionals in a laboratory environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In this study, the performance characteristics of the ROTEM® delta Whole Blood Haemostasis System (ROTEM®) were investigated and three assays were compared to the predicate device TEG® 5000 (TEG®) in support of a 510(k) submission for ROTEM®. The three ROTEM® tests NATEM, INTEM and HEPTEM were compared to their predicate tests on TEG®. The NATEM test represents the classical non-activated thrombelastographic method corresponding to the non-activated TEG®. The INTEM is activated by the intrinsic activator reagent ellagic acid corresponding to the intrinsically activated Kaolin test on TEG®. The HEPTEM is activated as the INTEM by ellagic acid and additionally contains heparinase for heparin neutralization corresponding to the Kaolin + Heparinase test of TEG®.
For all three tests, the ROTEM® was shown to have high precision in its primary parameter clot firmness and adequate precision in its secondary coagulation kinetics parameters.
The method comparison with TEG® showed equality of the clot firmness (MCF vs. MA). The kinetic parameters (CT vs. R, CFT vs. K, Alpha Angle vs. Angle) showed a linear correlation between ROTEM' and TEG® (r>0.8). As expected, slope of the correlation between the two systems was not equal to one and intercepts were not equal to zero in the kinetic parameters as the respective tests use different activation reagents and each test has its own distinct reference ranges. Heparin sensitivities of the respective intrinsic ROTEM® and TEG® tests also differed. ROTEM® was more sensitive for higher heparin concentrations than TEG® and allowed for an analysis of heparin concentrations normally seen during cardiovascular surgery; while TEG® was unable to demonstrate any coagulation in these cases.
Reference ranges for the ROTEM® tests NATEM and INTEM were estimated using CSL1 protocols on three clinical US reference sample aroups. The reference ranges determined showed no significant center-to-center deviations and were in accordance with the reference ranges determined in earlier studies on European reference sample groups.
Three interfering substances widely used in coagulation management, the antifibrinolytic drugs aprotinin, tranexamic acid and epsilon-amino caproic acid (EACA) were investigated. Dose-response curves were investigated for heparin, for dilution and for urokinase on the INTEM model in order to verify the diagnostic principles of thrombelastographic methods on ROTEM®.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
MAR 22 2010
510{k} Submission 2008/12/19
510(k) Summarv
1. Submitter's Name / Contact Person
Dr. Volker-Joachim Friemert Head of Quality Management and Regulatory Affairs Pentapharm GmbH Stahlgruberring 12 81829 Munich Germany
Contact:
| Office: | +49-89-454295-0 |
|---|---|
| Dr. Volker-Joachim Friemert: | +49-89-454295-11 |
| Fax: | +49-89-454295-22 |
| E-mail: | volker-joachim.friemert@rotem.de |
2. Identification of the Product
| Trade Name: | ROTEM® delta Thromboelastometry System |
|---|---|
| Common Name: | Whole Blood Haemostasis System |
| Classification Name: | Multipurpose System for In Vitro Coagulation |
| Studies |
3. Identification of the Predicate
Thrombelastograph® Coagulation Analyzer (TEG®) - 5000 Series K002177, Product Code JPA, Haemoscope Corp.
4. Description of the Device
The ROTEM® delta Thromboelastometry System consists of a fourcolumn instrument (with integrated computer module, computer controlled electronic pipette, software), system reagents (in-TEM® hep-TEM®, star-TEM®), quality controls (ROTROL N, ROTROL P) and measurement cells (Cup and Pin pro). The blood sample is filled into a cylindrical cup. A pin oscillates permanently while it is immersed in the blood holding cup. The motion of the pin is detected by an optical detection system. Data are processed and analyzed by a computer with special software. If no clotting takes place, the movement of the pin is not obstructed. When a clot forms and attaches itself to the pin and cup surfaces, the movement is obstructed. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational
1
movement of the pin is converted into an amplitude with the following definitions applying to the thromboelastogram (TEM): An amplitude of 0 mm means unobstructed rotation, while an amplitude of 100mm can be regarded as infinite firmness and blocking of the pin by the clot. The TEM amplitude is a measure of the clot firmness.
5. Intended Use
The ROTEM® delta Thromboelastometry System is designed for invitro diagnostic use by professionals in a laboratory environment. The ROTEM® system 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® system records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and Ivses 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 ROTEM® system provides specific blood modifiers (so-called reagents) intended to be used with the system, as additive to the blood sample.
The results of the ROTEM® analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history (anamnesis), the clinical picture and, if necessary, further coagulations tests.
| ROTEM® delta | TEG® 5000 | |
|---|---|---|
| Instrument | Fully integrated | |
| Thromboelastometry | ||
| instrument | Thrombelastography | |
| instrument | ||
| Measuring Technique | Shear elasticity of a | |
| coagulating sample | ||
| by motion of pin | Shear elasticity of a | |
| coagulating sample | ||
| by motion of cup | ||
| Measuring Channels | 4 | 2 |
| Signal Generation | Oscillating pin in | |
| stationary cup | Oscillation cup | |
| around stationary pin | ||
| Signal Transducer | Optical 4 CCD chips | Electrical-mechanical |
| transducer | ||
| Temperature Control | 30-40 ℃ | 20-40 ℃ |
| Sample Volume | 300 μl | 360 μl |
| Total Reaction Volume | 320-340 μl | 360-380 μl |
| Voltage | 110-230 V, 50-60 Hz | 120 V, 60 Hz and 220 V, 50 Hz model available |
| Environment | Stable and level surface. | |
| Operating temperature: 15-30 ℃. | ||
| Storage temperature 0-50 °C, | ||
| rel. humidity 20-85%. | Vibration free position, no solar radiation. | |
| Operating temperature: 10-35 °C. | ||
| Storage temperature -30-50 °C, | ||
| rel. humidity 20-80% | ||
| Operating Position | Level to 5°inclination | Level ad justed by leveling feet and level |
| Operable to Height above Sea Level | 2000 m (6560 ft) | 3048 m (10000 ft) |
| Initial Warm Up Time | 5-15 min (depending on room temperature) | 5 min |
| Pipetting | Electronic pipette (20-320 μl) | Manual pipettes (10, 20, 360, 1000 μl) |
| Reagents / Accessories: | in-TEM® (ellagic acid) | Kaolin |
| Intrinsic Contact Activation Reagent | ||
| Heparinase I Reagent (for heparin neutralization) | hep-TEM® (heparinase I, CaCl2) | Cup (single use) coated with heparinase I |
| or | ||
| Heparinase I reagent CaCl2 reagent | ||
| Calcium Chloride Reagent (for recalcification) | star-TEM® (CaCl2) | |
| Quality Control Material (level I control) | ROTROL N | TEG® coagulation control - level I |
| Quality Control Material (level II control) | ROTROL P | TEG® coagulation control - level II |
| Cups & Pins | Cup & Pin pro (Acrylic plastic) | Cups & Pins (Acrylic plastic) |
6. Summary of Technological Characteristics of the Product, Compared with the Predicate Device
2
3
7. Executive Summary of the Study Report
In this study, the performance characteristics of the ROTEM® delta Whole Blood Haemostasis System (ROTEM®) were investigated and three assays were compared to the predicate device TEG® 5000 (TEG®) in support of a 510(k) submission for ROTEM®. The three ROTEM® tests NATEM, INTEM and HEPTEM were compared to their predicate tests on TEG®. The NATEM test represents the classical non-activated thrombelastographic method corresponding to the non-activated TEG®. The INTEM is activated by the intrinsic activator reagent ellagic acid corresponding to the intrinsically activated Kaolin test on TEG®. The HEPTEM is activated as the INTEM by ellagic acid and additionally contains heparinase for heparin neutralization corresponding to the Kaolin + Heparinase test of TEG®.
For all three tests, the ROTEM® was shown to have high precision in its primary parameter clot firmness and adequate precision in its secondary coagulation kinetics parameters.
The method comparison with TEG® showed equality of the clot firmness (MCF vs. MA). The kinetic parameters (CT vs. R, CFT vs. K, Alpha Angle vs. Angle) showed a linear correlation between ROTEM' and TEG® (r>0.8). As expected, slope of the correlation between the two systems was not equal to one and intercepts were not equal to zero in the kinetic parameters as the respective tests use different activation reagents and each test has its own distinct reference ranges. Heparin sensitivities of the respective intrinsic ROTEM® and TEG® tests also differed. ROTEM® was more sensitive for higher heparin concentrations than TEG® and allowed for an analysis of heparin concentrations normally seen during cardiovascular surgery; while TEG® was unable to demonstrate any coagulation in these cases.
Reference ranges for the ROTEM® tests NATEM and INTEM were estimated using CSL1 protocols on three clinical US reference sample aroups. The reference ranges determined showed no significant center-to-center deviations and were in accordance with the reference ranges determined in earlier studies on European reference sample groups.
Three interfering substances widely used in coagulation management, the antifibrinolytic drugs aprotinin, tranexamic acid and epsilon-amino caproic acid (EACA) were investigated. Dose-response curves were investigated for heparin, for dilution and for urokinase on the INTEM model in order to verify the diagnostic principles of thrombelastographic methods on ROTEM®.
4
In summary, ROTEM® is a precise Whole Blood Haemostasis System with the typical performance characteristics of a thrombelastographic method (aprotinin interference on the contact activated and intrinsically activated tests, heparin sensitivity of the intrinsic test and sensitivity to dilution and lysis induced by urokinase in-vitro). Its reference ranges are reproducible from center to center. The method comparison with TEG® shows equality of the primary parameter clot firmness and a linear regression and good correlation in the secondary kinetic parameters. In comparison to the TEG® the ROTEM® is optimized for a rapid diagnosis (employing stronger activation for shorter activation and test times) accompanied by a shift of the detection range of heparin in the intrinsically activated test.
In aggregate the data presented in this report demonstrate that the ROTEM® system and the three assays described are substantially equivalent to the predicate TEG® System and corresponding assays.
8. Conclusion (Statement of Equivalence)
The data and information provided in this submission support a substantial equivalence determination, and, therefore, clearance of the 510(k) premarket notification for the ROTEM® delta Thromboelastometry System.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Pentapharm GinbH c/o Dr. Volker-Joachim Friemert Head of Quality Management and Regulatory Affairs Stahlgruberring 12 Munich, Germany 81829
MAR 2 3 2010
Re: K083842 Trade/Device Name: ROTEM® delta Thromboelastometry System: in-TEM® Assay hep-TEM® Assay NATEM® Assay Star-TEM® ROTEM® delta instrument ROTROL N ROTROL P Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA. GGN Dated: July 27, 2009 Received: July 29, 2009
Dear Dr. Friemert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21,
6
Page 2 - Dr. Friemert
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): KO83842
Device Name:
ROTEM® delta Thromboelastometry System
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.
Prescription Use) (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K083842
8
510(k) Submission 2008/12/19
Indications for Use
CONFIDENTIAL
510(k) Number (if known): K083842
Device Name: ROTROL N
Indications for Use
ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510/k
9
510(k) Submission 2008/12/19
Indications for Use
CONFIDENTIAL
510(k) Number (if known): K083842
Device Name: ROTROL P
Indications for Use
ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System.
' Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083842
10
CONFIDENTIAL
Indications for Use
510(k) Number: K083842 ·
Device Name: in-TEM® Assay
Indications for Use
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. Coagulations 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.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic
510(k) K083842
11
CONFIDENTIAL
Indications for Use
510(k) Number: K083842
Device Name: hep-TEM® Assay
Indications for Use
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. Coagulations 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.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off
510(k) K083842
12
510{k} Submission 2008/12/19
Indications for Use
CONFIDENTIAL
510(k) Number: K083842
Device Name: NATEM Assay
Indications for Use
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. Coagulations 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.
Prescription Use) X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diggnostic ice Evaluation and Safety
510(k) K083842
13
CONFIDENTIAL
Indications for Use
510(k) Number: K083842
Device Name: Star-TEM® Reagent
Indications for Use
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. Coagulations 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.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off
K083842
510(k)