(214 days)
No
The summary describes a standard immunoassay test performed on an automated analyzer and does not mention any AI or ML components. The use of a "clinical pretest probability (PTP) assessment model" is mentioned, but this refers to a clinical scoring system (like the Wells model), not an AI/ML model integrated into the device itself.
No
This device is an in vitro diagnostic test used to measure D-dimer levels for diagnostic purposes (to rule out DVT/PE), not for direct treatment of a condition.
Yes
The device is an automated, quantitative test used for the immunoenzymatic determination of D-dimer in human plasma, which is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients. Its purpose is to provide information for diagnosis or to rule out a condition.
No
The device description explicitly states it is an "automated quantitative test for use on the VIDAS instrument" and mentions physical components like the "Solid Phase Receptacle (SPR)" and "DD2 Reagent Strips," indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "immunoenzymatic determination of cross-linked fibrin degradation products (FbDP) containing the D-dimer domain in citrated human plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details an "automated quantitative test" using an "enzyme-linked fluorescent immunoassay (ELFA) technique" on a specific instrument. This is a typical description of an in vitro diagnostic assay.
- Sample Type: The test is performed on "citrated human plasma," which is a biological sample.
- Diagnostic Purpose: The test is indicated for use "in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE." This clearly indicates a diagnostic purpose – helping to rule out specific medical conditions.
N/A
Intended Use / Indications for Use
The VIDAS® D-Dimer New is an automated quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of fibrin degradation products (FbDP) in citrated human plasma using the ELFA techniques (Enzyme Linked Fluorescent Assay). The VIDAS" D-Dimer New assay is indicated for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep venous thrombosis (DVT) and Pulmonary Embolism (PE).
VIDAS® D-Dimer New is an automated, quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of cross-linked fibrin degradation products (FbDP) containing the D-dimer domain in citrated human plasma using the Enzyme Linked Fluorescent Assay (ELFA) technique. VIDAS D-Dimer New is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
The VIDAS® D-Dimer New (DD2) Assay is an automated quantitative test for use on the VIDAS instrument (K891385) for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma using the enzyme-linked fluorescent immunoassay (ELFA) technique. The instrument controls all assay steps and assay temperatures. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed DD2 Reagent Strips.
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
Not Found
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
Data was taken from a study carried out on 302 patients admitted consecutively to the emergency unit with suspected pulmonary embolism or deep venous thrombosis (frequency of venous thromboembolic disease: 23.7%).
Frozen samples collected from patients enrolled in a multi-center, prospective cohort study were used to validate the diagnostic utility of VIDAS D-Dimer New to exclude a diagnosis of deep vein thrombosis (DVT). Consecutive eligible outpatients (n = 556) with a first suspected DVT episode were evaluated at three hospitals during the course of the study. Using the previously validated, standardized clinical Wells model to estimate the probability of DVT, patients were classified as having a high, moderate, or low pretest probability (PTP) of DVT.
The VIDAS D-Dimer New assay was performed without knowledge of the PTP assessment results and the clinical outcome of the patients from which the samples were derived. A clinical cut off value of 500 ng FEU/ml was used. A D-dimer result of >>= 500 ng FEU/ml was considered positive and a result of
§ 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 Section J.
| Applicant Name and Address | |
|---|---|
| Applicant: | bioMerieux, Inc. |
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Sandra Perreand |
| Phone Number: | (314) 731-8594 |
| Fax Number: | (314) 731-8689 |
| Date of Preparation: | August 25, 2003 |
| Device Name | |
| Trade Name: | VIDAS D-Dimer New (DD2) Assay |
| Common Name: | Enzyme-linked Fluorescent Immunoassay (ELFA) for the quantitative |
| detection of fibrin degradation products (FbDP) | |
| Classification Name: | Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control |
| Predicate Device | |
| Trade Name: | VIDAS D-Dimer (DD) New Assay, K020810 |
Device Description
The VIDAS® D-Dimer New (DD2) Assay is an automated quantitative test for use on the VIDAS instrument (K891385) for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma using the enzyme-linked fluorescent immunoassay (ELFA) technique. The instrument controls all assay steps and assay temperatures. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed DD2 Reagent Strips.
Intended Use
The VIDAS® D-Dimer New is an automated quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of fibrin degradation products (FbDP) in citrated human plasma using the ELFA techniques (Enzyme Linked Fluorescent Assay). The VIDAS" D-Dimer New assay is indicated for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep venous thrombosis (DVT) and Pulmonary Embolism (PE).
Technological Characteristic Summary
Summary of Similarities and Differences to Predicate Device
Major Similarities Include:
-
- The VIDAS D-Dimer assays are identical except for the proposed modification in the Indications for Use.
Major Differences Include:
-
- The major difference between the two VIDAS assays is that we are expanding the indications for use for the assay.
1
Performance Data
Data was taken from a study carried out on 302 patients admitted consecutively to the emergency unit with suspected pulmonary embolism or deep venous thrombosis (frequency of venous thromboembolic disease: 23.7%).
For a cutoff at 500ng/ml, the results of the VIDAS D-Dimer New assay were as follows:
| Sensitivity: | 100% (95% CI, 95.0-100) |
|---|---|
| Specificity: | 33% (95% CI, 27.0-39.1) |
| Neg. Predictive Value: | 100% (95% CI, 95.3-100) |
Frozen samples collected from patients enrolled in a multi-center, prospective cohort study were used to validate the diagnostic utility of VIDAS D-Dimer New to exclude a diagnosis of deep vein thrombosis (DVT). Consecutive eligible outpatients (n = 556) with a first suspected DVT episode were evaluated at three hospitals during the course of the study. Using the previously validated, standardized clinical Wells model to estimate the probability of DVT, patients were classified as having a high, moderate, or low pretest probability (PTP) of DVT.
The VIDAS D-Dimer New assay was performed without knowledge of the PTP assessment results and the clinical outcome of the patients from which the samples were derived. A clinical cut off value of 500 ng FEU/ml was used. A D-dimer result of >>= 500 ng FEU/ml was considered positive and a result of