The Tina-quant® D-Dimer Test system is a particle enhanced immunoturbidimetric assay. Latex particles are coated with monoclonal antibodies to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-Dimer lead to an increase in turbidity.

AI/ML Overview

This is a 510(k) summary for a D-Dimer test system, which is an in vitro diagnostic device. The provided text does not include the specific acceptance criteria or the study data proving the device meets those criteria. It focuses on the device's description, intended use, and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor the details about the study design, sample sizes, expert involvement, and ground truth for a performance study.

The text does provide information in some of the other requested categories based on the context of a 510(k) submission for an in vitro diagnostic:

1. A table of acceptance criteria and the reported device performance:
* Not Available in the provided text. This information is typically found in the performance studies section of a 510(k) submission, detailing sensitivity, specificity, accuracy, precision, linearity, etc., and statistical results compared to pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not Available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
* Not Applicable/Available in the provided text. For an in vitro diagnostic device like a D-Dimer test, "ground truth" for a test set would typically be established by a reference method (e.g., another established D-Dimer assay, or clinical outcome data if demonstrating clinical utility), rather than by human expert consensus in the way a medical imaging device might. The document does not mention details of the reference method used in any performance studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not Applicable/Available in the provided text. Adjudication methods are typically used when human interpretation of data (e.g., images) forms part of the ground truth or comparison, which is not the case for this type of quantitative biochemical assay.

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 device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, by nature of the device. The Tina-quant® D-Dimer Test System is an automated immunoturbidimetric assay. Its performance is inherently standalone, as it provides quantitative results directly from a plasma sample without human interpretation of raw data beyond reading the numerical output. The "algorithm" in this context refers to the chemical and optical reactions and the instrument's processing of the turbidity changes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated in the provided text. For an in vitro diagnostic device like this, the "ground truth" in a validation study would typically be established by a well-characterized reference method or by clinical diagnosis/outcomes against which the D-Dimer levels are correlated.

8. The sample size for the training set:
* Not Applicable/Available in the provided text. This is an automated assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "development" of such an assay involves chemical formulation and calibration, not algorithm training on data.

9. How the ground truth for the training set was established:
* Not Applicable/Available in the provided text due to the nature of the device (see point 8).

Summary

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K030740

510(k) Summary - Tina-quant® D-Dimer Test System

APR 0 1 2003

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence
Submittername, address,contact	Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831
	Contact person: Sherri L. Coenen
	Date prepared: March 7, 2003
Device Name	Proprietary name: Tina-quant® D-Dimer Test System
	Common name: D-Dimer Test System
	Classification name: Fibrinogen/Fibrin Degradation Products Assay
Devicedescription	The Tina-quant® D-Dimer Test system is a particle enhancedimmunoturbidimetric assay. Latex particles are coated with monoclonalantibodies to the D-Dimer epitope. The antigen/antibody complexes producedby the addition of samples containing D-Dimer lead to an increase inturbidity.
Intended use	Immunoturbidimetric assay for the in vitro quantitative determination offibrin degradation products including D-Dimer and X-oligomers in plasma.
PredicateDevice	We claim substantial equivalence to the currently marketed Tina-quant® D-Dimer Test System. (K002706 and K011143).

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510(k) Summary - COBAS Integra Creatinine plus ver.2,

continued

The following table describes the similarities and differences between the Reagent Summary Tina-quant® D-Dimer Test System and the predicate device.

Topic	Tina-quant® D-dimeron Roche Hitachi(K002706)	Tina-quant® D-dimeron COBAS Integra(K011143)	Tina-quant® D-dimer(Modified Device)
Intended Use	Immunoturbidimetricassay for the in vitroquantitativedetermination of fibrindegradation productsincluding D-Dimer andX-oligomers.	The cassette COBASIntegra Tina-quant® D-Dimer contains an invitro diagnostic reagentsystem intended for useon COBAS Integrasystems for thequantitativeimmunologicaldetermination of fibrindegradation products (D-Dimer and X-oligomers)in plasma	Same
Method	Particle enhancedImmunoturbidimetric	Same	Same
Sample type	Citrated plasma	Same	Citrated plasmaLi-heparin plasma
Measuringrange	0.15 - 9.0 µg FEU/ml	Same	Same
Expectedvalues	< 0.5 µg FEU/ml	Same	Same

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of four stylized human profiles facing right, with three wavy lines above them. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

APR 0 1 2003

Re: K030740 Trade/Device Name: Tina-quant® D-Dimer Test System Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: II Product Code: GHH Dated: March 7, 2003 Received: March 10, 2003

Dear Ms. Coenen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to 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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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Tina-quant® D-Dimer Test System

Indications For Use:

Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Orosikene Kuntida

(Division Sigr Division of Clinical Laboratory Device 510(k) Number

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).