Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an automated immunoassay test and instrument, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is an automated quantitative test for the determination of fibrin degradation products, indicated for use in conjunction with clinical assessment for diagnosing DVT or PE. It is an in vitro diagnostic device, not a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the device 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," which clearly describes a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "automated quantitative test for use on the VIDAS instrument" and includes physical components like the Solid Phase Receptacle (SPR) and Reagent Strips. This indicates it is a hardware-based in vitro diagnostic device, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's 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." This describes a test performed on a biological sample (plasma) to provide information for the diagnosis or exclusion of a medical condition (DVT and PE).
Device Description: The description details an "automated quantitative test" using an "immunoenzymatic determination" technique on "human plasma." It also mentions the use of reagents and a specific instrument (VIDAS), all characteristic components of an in vitro diagnostic device.
Performance Studies: The document provides detailed performance data (sensitivity, specificity, PPV, NPV) based on testing human plasma samples from patients suspected of DVT or PE. This type of performance evaluation is standard for IVD devices.

The core function of the device is to analyze a biological sample (plasma) outside of the body (in vitro) to provide diagnostic information. This aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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).

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 (FbDP) in citrated human plasma using the ELFA techniques (Enzyme Linked Fluorescent Assay). The assay is indicated for use in conjunction with a clinical Pre-test Probability Assessment (PTP) assessment in excluding deep venous 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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 %.

VIDAS D-Dimer Performance-All Sites (Overall prevalence of PE= 23.0 %)
All Patients (n=965): Sensitivity 100 % (98.4-100%), Specificity 37.7 % (34.2-41.3%), NPV 100 % (98.7-100%), PPV 32.4 % (28.9-36.1%).

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 %
Sample size 891: Sensitivity 100 % (97.7-100%), Specificity 37.6 % (34.0-41.2%), NPV 100 % (98.7-100%), PPV 25.8 % (22.4-29.5%).

High pre test probability- Prevalence of PE= 83.1 %
Sample size 74: Sensitivity 100 % (94.3-100%), Specificity 45.5 % (16.7-76.6%), NPV 100 % (47.8-100%), PPV 91.3 % (82.0-96.7%).

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 (n=284): Sensitivity 100 % (94.1-100%), Specificity 38.1 % (31.7-44.8%), NPV 100 % (95.8-100%), PPV 30.7 % (24.3-37.6%).

Site 2- Geneva University Hospital, Geneva, Switzerland -Prevalence of PE= 20.5 %
All Patients (n=430): Sensitivity 100 % (95.9-100%), Specificity 38.6 % (33.4-44.0%), NPV 100 % (97.2-100%), PPV 29.5 % (24.4-35.1%).

Site 3- University Hospital, Lausanne, Switzerland-Prevalence of PE= 29.1 %
All Patients (n=251): Sensitivity 100 % (95.1-100%), Specificity 35.4 % (28.4-42.9%), NPV 100 % (94.3-100%), PPV 38.8 % (31.8-46.2%).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Overall Population (n=965):
Sensitivity: 100 % (98.4-100% CI)
Specificity: 37.7 % (34.2-41.3% CI)
NPV: 100 % (98.7-100% CI)
PPV: 32.4 % (28.9-36.1% CI)

Low & Intermediate Pre-test Probability (n=891):
Sensitivity: 100 % (97.7-100% CI)
Specificity: 37.6 % (34.0-41.2% CI)
NPV: 100 % (98.7-100% CI)
PPV: 25.8 % (22.4-29.5% CI)

High Pre-test Probability (n=74):
Sensitivity: 100 % (94.3-100% CI)
Specificity: 45.5 % (16.7-76.6% CI)
NPV: 100 % (47.8-100% CI)
PPV: 91.3 % (82.0-96.7% CI)

Site 1 (n=284):
Sensitivity: 100 % (94.1-100% CI)
Specificity: 38.1 % (31.7-44.8% CI)
NPV: 100 % (95.8-100% CI)
PPV: 30.7 % (24.3-37.6% CI)

Site 2 (n=430):
Sensitivity: 100 % (95.9-100% CI)
Specificity: 38.6 % (33.4-44.0% CI)
NPV: 100 % (97.2-100% CI)
PPV: 29.5 % (24.4-35.1% CI)

Site 3 (n=251):
Sensitivity: 100 % (95.1-100% CI)
Specificity: 35.4 % (28.4-42.9% CI)
NPV: 100 % (94.3-100% CI)
PPV: 38.8 % (31.8-46.2% CI)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K020810

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K891385

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

'JUN 1 0 2004

Image /page/0/Picture/1 description: The image shows a sequence of characters, specifically the string "K040882". The characters are written in a handwritten style, with varying stroke thicknesses. The text appears to be a code or identifier.

BIOMÉRIEUX

Section H.

510(k) Summary

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:	March 22, 2004
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:

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.

1

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 %)

| VIDA
S D-T
Dimer | | 1
1 | -------

Property Controller |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------|----------------------------------|
| (+) D-dimer | 000
1
Acres of the party | | 100 |
| dimer | | Ana
1 | A CLA
ﺗ
----------------- |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
012 | AAA
None 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 | 1

1 | E | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C
dimer | | | . A A A |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(-) D-dimer | | NAME OF OF | .
AFF |
| ota | | PROD | 00
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

2

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	t
14
, D-dimer
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 %
(94.1-100%)	38.1 %
(31.7-44.8%)	100 %
(95.8-100%)	30.7 %
(24.3-37.6%)

| VID A
mer | - | Charles Comments of Children | - All of the Research and control and concession of the proposes of the first of the first of the first of the first of the first of the first of the first of the first of th
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|
dimer | |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A P. P. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
dimer | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND IN R F. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. R. | A SHE LE LEAR CHALLER
LAND REGION OF
œ | |
| ----------------------------------------------------------------------------------------------
012 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Status Career Status
A REAL PROPERTY OF CHILING | AAA
-1 Box | consistent of the charges that the charges of the career of the county of the county of
Business of the Research of Children the Property of |

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

| All
Patients | % 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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
al development of the first the first to the controlled and concession the charges of the charges of the charges of the charges of the charges of the first
"
dimer	Annual Property
and the distribution of the control of	A 4 0
- - - -		CAR
1	150
------------
Annual Andrew Andrew And Annual Andrew Annual Andress of the Arman Comments of the Artistic Andress of the Artistic Station of the Artistics of the Artistic of the Artistic o
But A L C L C L C C C C C C C C C C C C C C . C . C . C
100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
112

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A And to concess couple . comes

00 | | . |

3

| All
Patients | % 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

4

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).

5

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

6

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