(121 days)
Not Found
No
The device description and performance studies focus on a turbidimetric assay based on antibody aggregation, which is a standard laboratory technique and does not involve AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
The device is an in vitro diagnostic assay used to aid in the diagnosis of certain conditions by quantifying a biomarker in human plasma. It does not directly treat or alleviate a disease, but rather provides information for diagnostic purposes.
Yes
The device aids in the diagnosis of venous thromboembolism (VTE) and is used to exclude pulmonary embolism (PE) disease, which are diagnostic purposes.
No
The device description clearly indicates it is a reagent kit involving polystyrene particles and a monoclonal antibody, which are physical components, not software.
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) in vitro (outside the body).
- Device Description: The description details a method for detecting D-dimers in samples using a reaction that occurs in vitro (aggregation of coated particles).
- Performance Studies: The performance studies describe testing "fresh specimens collected from 701 consecutive patients". This further confirms the use of patient samples in vitro.
The definition of an In Vitro Diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device clearly fits that description.
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 pulmonary embolism (PE) disease and as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggreated 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The INNOVANCE® D-Dimer assay was evaluated on the BCS® / BCS® XP System in a multicenter study to validate the exclusion of PE using fresh specimens collected from 701 consecutive patients presenting to the emergency department with suspected PE. Of these 701 patients, 54 were excluded for a total of 647 patients available for final analysis.
All patients were evaluated using the Wells' rules to estimate a high, moderate or low pre-test probability (PTP) of PE. Patient specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cutoff value of 0.5 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: ________________K091916
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1: Preparation:
Manufacturer:
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Str. 76 D-35001, Marburg Germany
Contact Information:
Siemens Healthcare Diagnostics Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date:
September 22, 2009
Device Name/ Classification: INNOVANCE® D-Dimer 2.
Class:
Panel:
Product Code:
Fibrinogen and Fibrin Split Product, Antigen, Antiserum and controls, Class II 21 CFR 864.7320 Hematology (HE) DAP
Identification of the Legally Marketed Device: 3.
VIDAS® D-Dimer Exclusion™ - K040882
4. Device Description:
Polystyrene particles covalently coated with a monoclonal antibody (8D3) are aggreated 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
5. 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 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)].
Medical device to which equivalence is claimed and comparison information: 6.
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 pulmonary embolism (PE) disease.
7. Device Performance Characteristics:
| Comparative Method | Slope | Intercept
(mg/L FEU) | Correlation
Coefficient | n |
|---------------------------|-------|-------------------------|----------------------------|-----|
| VIDAS® D-Dimer Exclusion™ | 1.11 | -0.075 | 0.96 | 265 |
The range of D-dimer values in the correlation studies was 0.17 to 4.17 mg/L FEU.
Clinical Study Summary
The INNOVANCE® D-Dimer assay was evaluated on the BCS® / BCS® XP System in a multicenter study to validate the exclusion of PE using fresh specimens collected from 701 consecutive patients presenting to the emergency department with suspected PE. Of these 701 patients, 54 were excluded for a total of 647 patients available for final analysis.
All patients were evaluated using the Wells' rules to estimate a high, moderate or low pre-test probability (PTP) of PE. Patient specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cutoff value of 0.5 mg/L (FEU). A D-dimer result