(370 days)
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No
The device description and performance studies focus on a turbidimetric assay and a fixed cutoff value, with no mention of AI or ML algorithms.
No.
This device is an in vitro diagnostic (IVD) tool designed for quantitative determination of D-dimers to exclude certain conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma" and "is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE)," which are diagnostic purposes.
No
The device description clearly outlines a physical assay involving polystyrene particles and a monoclonal antibody, which are hardware components used in a laboratory setting. The detection method is turbidimetry, which also requires hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma". This indicates the device is used to test a sample taken from the human body (plasma) to obtain information about a physiological state (presence and quantity of D-dimers).
- Device Description: The description details a method for detecting a substance (D-dimers) in a sample (plasma) using a chemical reaction (aggregation of coated particles). This is a typical characteristic of an in vitro diagnostic test.
- Clinical Performance: The provided performance data describes a study where patient specimens were tested with the device and the results were compared to clinical outcomes (presence or absence of DVT). This further confirms its use in a diagnostic context.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Healthcare Diagnostics and Sysmex® Coagulation Systems. The INNOVANCE® D-Dimer assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE).
Product codes
DAP
Device Description
Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggregated when mixed with samples containing D-dimer. The D-dimer crosslinkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an aggregation reaction, which is then detected turbidimetrically via the increase in turbidity.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 INNOVANCE® D-Dimer assay was evaluated on the BCS® / BCS® XP System in a multi-center study to validate the exclusion of DVT using fresh specimens collected from 455 consecutive patients presenting to the emergency department with suspected DVT. Of these 455 patients, 29 were excluded for a total of 426 patients available for final analysis. All patients were evaluated using the Wells' rules to estimate a likely or unlikely pre-test probability (PTP) of DVT. Patient specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cutoff value of 0.50 mg/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
510(k) Summary for INNOVANCE® D-Dimer 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:
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:
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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:
November 23, 2009
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- Device Name/ Classification: INNOVANCE® D-Dimer
Class:
- Device Name/ Classification: INNOVANCE® D-Dimer
Panel:
Fibrinogen and Fibrin Split Product, Antigen, Antiserum and controls, Class II 21 CFR 864.7320 Hematology (HE) DAP
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- Identification of the Legally Marketed Device:
VIDAS® D-Dimer Exclusion™ - K040882
- Identification of the Legally Marketed Device:
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- Device Description:
Product Code:
- Device Description:
Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggregated when mixed with samples containing D-dimer. The D-dimer crosslinkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an aggregation reaction, which is then detected turbidimetrically via the increase in turbidity.
1
ട. Device Intended Use:
INNOVANCE® D-Dimer:
For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Healthcare Diagnostics and Sysmex® Coagulation Systems. The INNOVANCE® D-Dimer assay is intended for use in coniunction with a non-high clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE).
6. Medical device to which equivalence is claimed and comparison information:
The INNOVANCE® D-Dimer is substantially equivalent to the VIDAS® D-Dimer Exclusion™ (K040882) assay. The INNOVANCE® D-Dimer method, like the VIDAS® D-Dimer Exclusion™ method, is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease.
7. Device Performance Characteristics:
Clinical Performance of the INNOVANCE® D-Dimer assay to exclude DVT
The INNOVANCE® D-Dimer assay was evaluated on the BCS® / BCS® XP System in a multi-center study to validate the exclusion of DVT using fresh specimens collected from 455 consecutive patients presenting to the emergency department with suspected DVT. Of these 455 patients, 29 were excluded for a total of 426 patients available for final analysis.
All patients were evaluated using the Wells' rules to estimate a likely or unlikely pre-test probability (PTP) of DVT. Patient specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cutoff value of 0.50 mg/L (FEU). A D-dimer result