Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids 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).

Device Description

Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products containing 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

Here's a breakdown of the acceptance criteria and study information for the Advanced D-Dimer device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state pre-defined "acceptance criteria" in a numerical or categorical format for the correlation and precision studies. Instead, it presents the results of a comparison against a predicate device and internal precision measurements. However, we can infer the performance that was demonstrated andpresumably deemed acceptable for substantial equivalence.

Performance Metric	Implied ("Accepted") Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Correlation to Predicate Device (Asserachrom® D-Di)	High correlation (e.g., above 0.90)	Correlation coefficient: 0.91
	Near 1.0 slope	Slope: 0.98
	Near 0.0 y-intercept	Y-intercept: 0.54
Inter-assay Precision	Low variability	Ranged from 0.8% to 3.8%
Intra-assay Precision	Low variability	Ranged from 1.3% to 3.0%

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

Sample Size for Correlation Study (Test Set): 316 samples
Data Provenance: The document does not specify the country of origin of the data or whether the samples were collected retrospectively or prospectively. It only states "human plasma".

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

This information is not provided in the document. The study described is a comparison of the Advanced D-Dimer assay to a legally marketed predicate device (Asserachrom® D-Di), not a study against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The study compared the new device to a predicate device, not to a ground truth adjudicated by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study presented compares the performance of the Advanced D-Dimer assay to an existing diagnostic assay (Asserachrom® D-Di), not the performance of human readers with or without AI assistance.

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

Yes, a standalone performance evaluation was done. The Advanced D-Dimer is an in vitro diagnostic device, and its performance (e.g., correlation and precision) was evaluated independently as a standalone assay. It is designed to provide quantitative measurements without human interpretation or intervention in the measurement process itself, beyond laboratory operation.

7. The Type of Ground Truth Used:

The "ground truth" for the correlation study was the results obtained from the legally marketed predicate device, Asserachrom® D-Di. For the precision studies, the ground truth was implied by the expected values of the control materials and human plasma pools, evaluated for consistency.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The Advanced D-Dimer is a conventional in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and immunological principles of the assay itself.

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

This information is not applicable/provided for the reason mentioned in point 8.

Summary

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K992957

Advanced D-Dimer 510(k) Notification K992957 Additional Information

510(k) Summary for Advanced D-Dimer

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: _____________________________

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

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 76Marburg/Germany
Contact Information:	Dade Behring Inc.Glasgow SiteP.O. Box 6101Newark, Delaware 19714Attn: Rebecca S. AyashTel: 302-631-6276
Preparation date:	December 3, 1999

Device Name/ Classification: 2.

Advanced D-Dimer:	Fibrinogen/fibrin degradation products assay
Classification Number:	Class II (864.7320)

ldentification of the Legally Marketed Device: 3.

Asserachrom® D-Di (K862156)

4. Device Description:

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5. Device Intended Use:

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 a Dade Behring Coagulation Analyzer.

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

There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma. One such product is the Asserachrom® D-Di (K862156). Advanced D-Dimer is substantially equivalent in intended use and results obtained to the Asserachrom® D-Di. The Advanced D-Dimer, like Asserachrom® D-Di is intended to be used for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in human plasma.

7. Device Performance Characteristics:

Correlation:

The Advanced D-Dimer assay was compared to the Asserachrom® D-Di by evaluating 316 samples ranging from 0.43 to 85.9 mg/l. A correlation coefficient of 0.91 was obtained, with a y-intercept value of 0.54 and a slope of 0.98.

Precision:

Precision studies were performed by the evaluation of two levels of control material and two levels of human plasma pools in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 0.8 to 3.8%, while the intra-assay precision ranged from 1.3 to 3.0%.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

JAN 2 8 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Avash Manager, Regulatory Affairs, Biology Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

Re: K992957 Trade Name: Advanced D-Dimer Regulatory Class: II Product Code: DAP Dated: December 3, 1999 Received: December 6, 1999

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Advanced D-Dimer 510(k) Notification K992957 Additional Information

Indications Statement

Device Name: Advanced D-Dimer

Indications for Use:

Otto G. Macion

(Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number --

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

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).