Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with Dade Behring Coagulation Analyzes and Sysmex® Coagulation Systems. The Advanced D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

Device Description

Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products (D-dimer) are agglutinated when mixed with samples containing D-dimer. The cross-linkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an agglutination reaction, which is then detected turbidimetrically via the increase in turbidity.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Advanced D-Dimer Assay." This device is an in-vitro diagnostic test and does not fall under the typical scope of AI/ML-driven devices that would require the description of acceptance criteria, study details, and performance metrics as outlined in the request.

Therefore, many of the requested fields are not applicable to this type of traditional in-vitro diagnostic device and its 510(k) submission.

However, I can extract the relevant information that is present in the document.

1. Table of acceptance criteria and the reported device performance:

The document describes the device performance in a table format, but it does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve >X% sensitivity and >Y% specificity"). Instead, it presents some numerical data, which given the context of a D-Dimer assay, likely refers to patient numbers or performance characteristics, but without clear labels, it's hard to interpret precisely. The table is also poorly formatted and illegible in parts.

Performance Metric	Reported Device Performance (Dade Behring BCS System)	Reported Device Performance (Sysmex A-1500)
A Book Same Bear washing more and	000 SIL	297
and and a province	108% 3-2 1 4 hours and 11 8 2 4 1 4 5 3 4 1 1 7 3 1 1 1 1 1 1 1 1 1 1 1	100
A BAND BE PART A C R C S . C . S.	છેકે 38	100
STORES OF COLLECTION	173 2008 200	ਰੇਰੇ 100

Note: The content and labels in this table are heavily garbled and appear to be misinterpretations of the original text. It is highly likely the original document contained clinical performance data (sensitivity, specificity, NPV, PPV) based on the intended use for DVT/PE diagnosis, but this specific section is unreadable in the provided text.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated for performance evaluation. The table includes numbers like "173 2008 200" and "297", which could relate to sample sizes or collection sites, but without a clear label, it's impossible to confirm.
Data provenance: Not explicitly stated (e.g., country of origin). The study is simply referred to as "Advanced D-Dimer Clinical Study Summary."
Retrospective or prospective: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. For a D-Dimer assay, the "ground truth" for VTE diagnosis would typically be established through definitive objective diagnostic tests (e.g., venography, CT pulmonary angiography) rather than expert consensus on device output. The document describes a laboratory test, not an interpretive image or signal.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically for interpreting subjective outputs (e.g., radiology images) to establish ground truth. For a quantitative D-Dimer assay, the "ground truth" for the presence or absence of DVT/PE would come from objective diagnostic tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is an in-vitro diagnostic assay, not an AI-driven imaging or diagnostic tool intended to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a laboratory assay; its performance is inherently "standalone" in the sense that it measures a biomarker concentration. It doesn't involve an "algorithm" in the AI sense or a "human-in-the-loop" for interpretation of its primary result. Its clinical utility is then interpreted by a clinician in the context of other patient information.

7. The type of ground truth used:

Implied: For a D-Dimer assay intended as an aid in diagnosing DVT/PE, the ground truth for the presence or absence of DVT/PE would typically be established by definitive objective diagnostic imaging studies (e.g., venography for DVT, CT pulmonary angiography for PE) or a combination of clinical assessment and follow-up. The document does not explicitly state which gold standard tests were used.

8. The sample size for the training set:

Not applicable/Not mentioned. This is a traditional chemical assay, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no "training set" for this type of device.

Summary

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AUG 1 1 2004

510(k) Summary for Advanced 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: _ Ko4 1438

Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date:

May 28, 2004

Device Namel Classification: Advanced D-Dimer Assay 2. Fibrinogen and Fibrin Split Product, Class II, Class: 21 CFR 864.7320 Hematology (HE) Panel: DAP Product Code:

Identification of the Legally Marketed Device: 3.

Advanced D-Dimer Assay (K992957)

Device Description: 4.

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Device Intended Use: 5.

Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative Advanced D Dimor is a fatox of handed and on products containing D-dimer in human determination of orders liching Coagulation Analyzers and Sysmex® Coagulation plasma for use with Dado Doning Oosay is intended for use as an aid in the diagnosis of Systems: The Auvanood ‫(VTE) Jdeep vein thrombosis (DVT) or pulmonary embolism (PE)].

Medical device to which equivalence is claimed and comparison information: 6.

The modified Advanced D-Dimer assay is substantially equivalent in intended use to the The modified Advanced D-Dimer corrently marketed (K992957). The modified Advanced D-Dimer assay, like the current Advanced D-Dimer assay, is intended for the quantitative doody, like the ourrent interest tion products containing D-dimer in human determination of or order linked fining Coagulation Analyzers Sysmex Coagulation Systems.

Device Performance Characteristics: 7.

Advanced D-Dimer Clinical Study Summary

111111111111 11 11 11 1 2 1111 15 2 1011 11111 11 11 1 1 12 1011 11 111111A Book Same Bearwashing more and	and and a province108% 3-2 1 4 hours and 11 8 2 4 1 4 5 3 4 1 1 7 3 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1	.	A BAND BE PARTA C R C S . C . S.2017 28		STORES OF COLLECTION173 2008 200
BCS"System	000SIL		છેકે	38	ਰੇਰੇ
A-1500Sysmex	297		100	l Children Children Children Children Children Children Station of Children Children Station of Children Station of Children Station of Children Station of Children Station oﺮ	100

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714

AUG 1 1 2004

K041438 Re:

Trade/Device Name: Advance D-Dimer Assay Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin degradation products assay Regulatory Class: II Product Code: DAP Dated: May 28, 2004 Received: June 2, 2004

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerest. 976 the enactment date of the Medical Device Amendments, or to conniner or prist to ria) 2011-03-2014 in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmeter For (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, mainer of the Act include requirements for annual registration, listing of general controls provision 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 If your do rioe is excerined controls. Existing major regulations affecting your device can may or sabyer to basil at basil at the material 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 r toate be acternination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice Of it rate of 7, as the g requirements o begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2

If you desire specific information about the application of labeling requirements to your device, rr you destre specific movies and advertising of your device, please contact the Office of In of questions on the promise Evaluation and Safety at (301) 594-3084. Also, please note the v Hro Diagnetitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Four inay of Small Manufacturers, International 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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices 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): K041438

Device Name: Advanced D-Dimer

Indications For Use:

Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative A lovernination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with Dade Behring Coagulation Analyzes and Sysmex® Coagulation plasma for ass war Daal D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mana Chan for
Josephine Bautista
Division Sign-Off

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnomic Device Evaluation and sty

510(k) K041438

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).