(104 days)
Not Found
No
The device description details a standard immunoassay technology and data analysis is performed by a microprocessor, with no mention of AI or ML.
No
The device is an in vitro diagnostic test used for quantitative measurement of D-dimer, aiding in diagnosis and exclusion of certain conditions, rather than directly treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Stratus® CS Acute Care™ D-dimer assay "is an in vitro diagnostic test" intended as "an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]".
No
The device description clearly outlines a physical assay method (Radial Partition Immunoassay) performed on a specific analyzer (Stratus® CS analyzer), indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Stratus® CS Acute Care™ D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Stratus® CS Acute Care™ D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer. The Stratus® CS Acute Care™ DDMR assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) disease and as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. This assay is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
Product codes
DAP
Device Description
The Stratus® CS Acute Care™ D-Dimer method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the D-dimer molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS STAT Fluorometric Analyzer (Stratus® CS analyzer) by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of D-dimer in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
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
Not Found
Intended User / Care Setting
trained health care professionals in the clinical laboratory and point of care (POC) settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The Stratus® CS Acute Care™ D-Dimer assay was evaluated on the Stratus® CS analyzer in a multi-center study to validate the exclusion of PE using fresh citrated plasma specimens collected from 730 consecutive patients presenting to the emergency department with suspected PE. Of these 730 patients, 75 were excluded for a total of 655 patients available for final analysis. All patients were evaluated using the Wells' rules to estimate a high, moderate or low pretest probability (PTP) of PE. Patient specimens were tested with the Stratus® CS Acute Care™ D-Dimer assay and results were compared to a cutoff value of 450 ng/mL [µg/L] (FEU). A D-dimer result
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
0
MAY 16 2011
510(k) Summary for Stratus CS Acute Care DDMR Assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K 110303
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- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer:
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Str. 76 D-35001, Marburg Germany
Contact Information:
Siemens Healthcare Diagnostics Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
April 19, 2011
- Device Name/ Classification: Stratus® CS Acute Care™ D-Dimer assay 2.
Class:
Panel:
Fibrinogen and Fibrin Split Product, Antigen, Antiserum and controls, Class II 21 CFR 864.7320 Hematology (HE) DAP
3. Identification of the Legally Marketed Device:
Innovance D-Dimer - K093626
4. Device Description:
Product Code:
The Stratus® CS Acute Care™ D-Dimer method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the DDMR TestPak. This antibody recognizes a distinct antigenic site on the D-dimer molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the D-dimer molecule is pipetted onto the reaction zone of the paper. During this second incubation
1
period, enzyme-labeled antibody reacts with the bound D-dimer, forming an antibodyantigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS STAT Fluorometric Analyzer (Stratus® CS analyzer) by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of D-dimer in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
5. Device Intended Use:
The Stratus® CS Acute Care™ D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer. The Stratus® CS Acute Care™ DDMR assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) disease and as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. This assay is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings
Medical device to which equivalence is claimed and comparison information: 6.
The Stratus® CS DDMR assay is substantially equivalent to the Innovance D-Dimer (K093626) assay. The Stratus® CS DDMR method, like the Innovance D-Dimer method, is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) disease.
7. Device Performance Characteristics:
Clinical Performance of the Stratus® CS Acute Care™ D-Dimer assay to exclude PE in Citrated Plasma
The Stratus® CS Acute Care™ D-Dimer assay was evaluated on the Stratus® CS analyzer in a multi-center study to validate the exclusion of PE using fresh citrated plasma specimens collected from 730 consecutive patients presenting to the emergency department with suspected PE. Of these 730 patients, 75 were excluded for a total of 655 patients available for final analysis.
All patients were evaluated using the Wells' rules to estimate a high, moderate or low pretest probability (PTP) of PE. Patient specimens were tested with the Stratus® CS Acute Care™ D-Dimer assay and results were compared to a cutoff value of 450 ng/mL [[gg/L] (FEU), A D-dimer result