VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442

K040882 · bioMerieux, Inc. · DAP · Jun 10, 2004 · Hematology

Device Facts

• Record ID: K040882
• Device Name: VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
• Applicant: bioMerieux, Inc.
• Product Code: DAP · Hematology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

The VIDAS® D-dimer Exclusion Assay is an automated quantitative test for the immunoenzymatic determination of fibrin degradation products (FbDP) in citrated human plasma using the ELFA (Enzyme Linked Fluorescent Assay). The VIDAS® D-dimer Exclusion Assay is indicated for use in conjunction with a clinical Pre-test Probability Assessment (PTP) assessment model to exclude deep venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.

Device Story

The VIDAS D-Dimer Exclusion Assay is an automated, quantitative, enzyme-linked fluorescent immunoassay (ELFA) performed on the VIDAS analyzer. It measures fibrin degradation products (FbDP) in citrated human plasma. The system utilizes a Solid Phase Receptacle (SPR) that functions as both a solid phase and a pipettor for the assay. Reagents are pre-dispensed in sealed strips. The device is intended for use in clinical settings to assist healthcare providers in excluding DVT and PE in symptomatic outpatients. By integrating assay results with a clinical Pre-test Probability (PTP) assessment, the device helps clinicians rule out these conditions, potentially reducing the need for further diagnostic imaging or invasive procedures. The instrument automates all assay steps and temperature controls.

Clinical Evidence

Clinical evidence includes two multi-center prospective cohort studies. DVT study (n=556) and PE study (n=965). Patients evaluated using Wells (DVT) or WICKIE (PE) pre-test probability models. Primary endpoint: negative predictive value (NPV) for VTE exclusion. Results: NPV for DVT exclusion was 100% (95% CI: 97.8-100.0). NPV for PE exclusion was 100% (95% CI: 98.7-100.0). Sensitivity was 100% across all probability groups.

Technological Characteristics

ELFA-based quantitative immunoassay. Components: polypropylene reagent strips, anti-D-Dimer mouse monoclonal immunoglobulin-coated Solid Phase Receptors (SPR), lyophilized FbDP controls/calibrators. Energy source: VIDAS analyzer-integrated. Detection: fluorometric measurement at 450 nm. Connectivity: Master Lot Entry (MLE) barcode for curve calibration. Automated processing.

Indications for Use

Indicated for the quantitative determination of fibrin degradation products (FbDP) in citrated human plasma to aid in the exclusion of deep venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE, when used in conjunction with a clinical Pre-test Probability Assessment (PTP) model.

Predicate Devices

• bioMerieux VIDAS D-Dimer (DD) New Assay-Exclusion DVT Claim (K030328)

Submission Summary (Full Text)

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'JUN 1 0 2004

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# BIOMÉRIEUX

#### Section H.

#### 510(k) Summary

| Applicant Name and Address | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Applicant: | bioMerieux, Inc. |
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Sandra Perreand |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Preparation: | March 22, 2004 |
| Device Name | |
| Trade Name: | VIDAS D-Dimer New (DD2) Assay |
| Common Name: | Enzyme-linked Fluorescent Immunoassay (ELFA) for the<br>quantitative detection of fibrin degradation products (FbDP) |
| Classification Name: | Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control |
| Predicate Device<br>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:

- 1) The VIDAS D-Dimer assays are identical except for the proposed modification in the Indications for Use.
Major Differences Include:

- 1) The major difference between the two VIDAS assays is that we are expanding the indications for use for the assay.

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# Performance Data

Data from a three site prospecitive patient management study was presented. The results were as follows:

The observed sensitivity, specificity, PPV and NPV (with exact 95% Confidence Intervals) and I me doese for all PE suspected patients (n=965) from all sites and all pre-test probability scores combined are shown below. The prevalence of PE was 23.0 %.

| All Patients | % Sensitivity<br>(95% CI) | % Specificity<br>(95% CI) | % NPV<br>(95% CI) | % PPV<br>(95% CI) |
|--------------|---------------------------|---------------------------|----------------------|------------------------|
| 965 | 100 %<br>(98.4-100%) | 37.7 %<br>(34.2-41.3%) | 100 %<br>(98.7-100%) | 32.4 %<br>(28.9-36.1%) |

VIDAS D-Dimer Performance-All Sites (Overall prevalence of PE= 23.0 %)

| VIDA<br>S D-T<br>Dimer | | 1<br>1 | -------<br>- Property Controller |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------|----------------------------------|
| (+) D-dimer | 000<br>1<br>Acres of the party | | 100 |
| dimer | | Ana<br>1 | A CLA<br>ﺗ<br>----------------- |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>012 | AAA<br>None of Concess of<br> | | |

The observed sensitivity, specificity, PPV and NPV (with exact 95% Confidence Intervals) and prevalence for all PE suspected patients (n=965) from all sites combined by pre test probability are shown below.

#### Low and intermediate (moderate) pre test probability- Prevalence of PE= 17.8 %

| Low & Intermediate | % Sensitivity (95% CI) | % Specificity (95% CI) | % NPV (95% CI) | % PPV (95% CI) |
|--------------------|------------------------|------------------------|----------------------|------------------------|
| 891 | 100 %<br>(97.7-100%) | 37.6 %<br>(34.0-41.2%) | 100 %<br>(98.7-100%) | 25.8 %<br>(22.4-29.5%) |

| VIDAS D-Dimer | 1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1 | E | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C<br>dimer | | | . A A A |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>(-) D-dimer | | NAME OF OF | .<br>AFF |
| ota | | PROD | 00<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

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| High pre test probability- Prevalence of PE= 83.1 % | | | | |
|-----------------------------------------------------|---------------------------|---------------------------|----------------------|------------------------|
| High | % Sensitivity<br>(95% CI) | % Specificity<br>(95% CI) | % NPV<br>(95% CI) | % PPV<br>(95% CI) |
| 74 | 100 %<br>(94.3-100%) | 45.5 %<br>(16.7-76.6%) | 100 %<br>(47.8-100%) | 91.3 %<br>(82.0-96.7%) |

ore test probability- Prevalence of PE= 85,1 % U: ... .

| VIDAS D-Dimer | | + TT | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------|---------|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| . (+) D-dimer | t<br>14 | | |
| , D-dimer<br>t | | | |
| otal | 100 | 1 | |

#### VIDAS D-Dimer Performance-By Site D.

The observed sensitivity, specificity, PPV and NPV (with exact 95% Confidence Intervals) for PE suspected patients by site are shown below.

Site 1- Angers University Hospital, Angers, France- Prevalence of PE= 21.5 %

| All Patients | % Sensitivity (95% CI) | % Specificity (95% CI) | % NPV (95% CI) | % PPV (95% CI) |
|--------------|------------------------|------------------------|----------------------|------------------------|
| 284 | 100 %<br>(94.1-100%) | 38.1 %<br>(31.7-44.8%) | 100 %<br>(95.8-100%) | 30.7 %<br>(24.3-37.6%) |

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# Site 2- Geneva University Hospital, Geneva, Switzerland -Prevalence of PE= 20.5 %

| All<br>Patients | % Sensitivity<br>(95% CI) | % Specificity<br>(95% CI) | % NPV<br>(95% CI) | % PPV<br>(95% CI) |
|-----------------|---------------------------|---------------------------|----------------------|------------------------|
| 430 | 100 %<br>(95.9-100%) | 38.6 %<br>(33.4-44.0%) | 100 %<br>(97.2-100%) | 29.5 %<br>(24.4-35.1%) |

| VIDAS D-Dimer | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------|-----|
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| All<br>Patients | % Sensitivity<br>(95% CI) | % Specificity<br>(95% CI) | % NPV<br>(95% CI) | % PPV<br>(95% CI) |
|-----------------|---------------------------|---------------------------|----------------------|------------------------|
| 251 | 100 %<br>(95.1-100%) | 35.4 %<br>(28.4-42.9%) | 100 %<br>(94.3-100%) | 38.8 %<br>(31.8-46.2%) |

Site 3- University Hospital, Lausanne, Switzerland-Prevalence of PE= 29.1 %

| VIDAS D-Dimer | PE (+) | PE (-) | Total |
|---------------|--------|--------|-------|
| (+) D-dimer | 73 | 115 | 188 |
| (-) D-dimer | 0 | 63 | 63 |
| Total | 73 | 178 | 251 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

JUN 1 0 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sandra Perreand Director, Regulatory Affairs Biomerieux, Inc. 595 Anglum Road Hazelwood, MO 63042

k040882 Re:

Trade/Device Name: VIDAS D-Dimer Exclusion Assay Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP Dated: April 2, 2004 Received: April 5, 2004

Dear Ms. Perreand:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your wear your see is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of 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, de noos that hat (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 r ou may, arerer crovisions 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device ic may or buyer to access and 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 that I Dr has Intacted and regulations administered by other Federal agencies. You must or any 1 odelar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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## Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket nothication: The PDA Inding of backantal vine
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of II you desire specific miorination acounts of your device, please contact the Office of of questions on the promotion and advertising on and Safety at [phone]. Also, please note the In Viro Diagliostic Device Evanadon and Bases of premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may bolain onlier general intornational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: VIDAS D-Dimer Exclusion Assay

#### Indications for Use:

The VIDAS® D-Dimer Exclusion assay is an automated quantitative test for use on The VIDAS analyzers for the immunoenzymatic determination of fibrin degradation the VIDTD and years rated human plasma using the ELFA techniques (Enzyme products (I oDT ) in chrated namal passant as as agent is indicated for Linked Probection with a clinical Pre-test Probability Assessment (PTP) assessment ace in confusionel was venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suphine Bantiste
Division/Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K040882