The VIDAS® D-Dimer Exclusion assay is an automated quantitative test for use on The VIDAS analyzers for the immunoenzymatic determination of fibrin degradation 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.

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.

AI/ML Overview

This is a summary of the acceptance criteria and study findings for the VIDAS D-Dimer New Assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the observed performance in the clinical study, particularly the 100% Negative Predictive Value (NPV) and high sensitivity, which are critical for an exclusion assay. The study aims to demonstrate that the device is effective in ruling out DVT and PE.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Overall)	Reported Device Performance (Low & Intermediate PTP)	Reported Device Performance (High PTP)
Sensitivity	High (ideally 100% or very close)	100% (98.4-100% CI)	100% (97.7-100% CI)	100% (94.3-100% CI)
Specificity	Good enough to reduce unnecessary imaging while maintaining high sensitivity	37.7% (34.2-41.3% CI)	37.6% (34.0-41.2% CI)	45.5% (16.7-76.6% CI)
NPV	High (ideally 100% for exclusion)	100% (98.7-100% CI)	100% (98.7-100% CI)	100% (47.8-100% CI)
PPV	Reasonable	32.4% (28.9-36.1% CI)	25.8% (22.4-29.5% CI)	91.3% (82.0-96.7% CI)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Overall: 965 PE suspected patients
- Low and Intermediate Pre-test Probability: 891 patients
- High Pre-test Probability: 74 patients
- Site 1 (Angers University Hospital, France): 284 patients
- Site 2 (Geneva University Hospital, Switzerland): 430 patients
- Site 3 (University Hospital, Lausanne, Switzerland): 251 patients
Data Provenance: Three-site prospective patient management study conducted in:
- Angers University Hospital, Angers, France
- Geneva University Hospital, Geneva, Switzerland
- University Hospital, Lausanne, Switzerland

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. However, a "clinical Pre-test Probability Assessment (PTP) model" is mentioned as being used in conjunction with the assay, implying clinical evaluation by medical professionals. For DVT/PE diagnosis, the ground truth typically involves a combination of imaging studies (e.g., CT pulmonary angiography, ventilation-perfusion scan for PE; ultrasound for DVT) and clinical assessment.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for establishing the ground truth diagnoses of PE for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This study focuses on the standalone performance of the VIDAS D-Dimer assay in conjunction with a PTP model for DVT/PE exclusion, not on comparing human readers with and without AI assistance.

6. Standalone Performance

Yes, a standalone performance study was conducted. The reported metrics (Sensitivity, Specificity, NPV, PPV) are for the VIDAS D-Dimer New Assay itself, in conjunction with a clinical Pre-test Probability Assessment.

7. Type of Ground Truth Used

The ground truth for the presence or absence of DVT/PE is implicitly clinical diagnosis, likely established through standard diagnostic protocols for DVT and PE (e.g., imaging, clinical probability scores, and follow-up). The prevalence of PE is reported, indicating confirmed diagnoses.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size. The performance data presented is from a clinical validation study (test set). For an immunoassay like this, the device itself is not "trained" in the same way a machine learning algorithm is. Its performance characteristics are determined by its chemical and biological detection mechanism, which would have been developed and validated internally by the manufacturer, but details of that development (e.g., sample sizes for assay development or internal validation) are not included in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a separate "training set" with ground truth in the context of an immunoassay is not directly applicable in the same way it is for AI/ML devices. The assay's analytical performance and cutoff values would have been established through laboratory studies during development using known positive and negative samples, but these details are not provided in this regulatory submission.

Summary

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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 RoadHazelwood, MO 63042
Contact Person:	Sandra Perreand
Phone Number:	(314) 731-8594
Fax Number:	(314) 731-8689
Date of Preparation:	March 22, 2004
Device Name
Trade Name:	VIDAS D-Dimer New (DD2) Assay
Common Name:	Enzyme-linked Fluorescent Immunoassay (ELFA) for thequantitative detection of fibrin degradation products (FbDP)
Classification Name:	Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control
Predicate DeviceTrade Name:	VIDAS D-Dimer (DD) New Assay, K020810

Device Description

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(95% CI)	% Specificity(95% CI)	% NPV(95% CI)	% PPV(95% CI)
965	100 %(98.4-100%)	37.7 %(34.2-41.3%)	100 %(98.7-100%)	32.4 %(28.9-36.1%)

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

VIDAS D-TDimer		11	-------- Property Controller
(+) D-dimer	0001Acres of the party		100
dimer		Ana1	A CLAﺗ-----------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------012	AAANone of Concess of

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 %(97.7-100%)	37.6 %(34.0-41.2%)	100 %(98.7-100%)	25.8 %(22.4-29.5%)

VIDAS D-Dimer	E
Cdimer		. A A A
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(-) D-dimer	NAME OF OF	.AFF
ota	PROD	00------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

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

VIDAS D-Dimer		+ TT
. (+) D-dimer	t14
, D-dimert
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 %(94.1-100%)	38.1 %(31.7-44.8%)	100 %(95.8-100%)	30.7 %(24.3-37.6%)

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

AllPatients	% Sensitivity(95% CI)	% Specificity(95% CI)	% NPV(95% CI)	% PPV(95% CI)
430	100 %(95.9-100%)	38.6 %(33.4-44.0%)	100 %(97.2-100%)	29.5 %(24.4-35.1%)

VIDAS D-Dimer
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AllPatients	% Sensitivity(95% CI)	% Specificity(95% CI)	% NPV(95% CI)	% PPV(95% CI)
251	100 %(95.1-100%)	35.4 %(28.4-42.9%)	100 %(94.3-100%)	38.8 %(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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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

Page 1 of 1

510(k) K040882

Regulation Number and Section

§ 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).