MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM

K030740 · Roche Diagnostics Corp. · GHH · Apr 1, 2003 · Hematology

Device Facts

• Record ID: K030740
• Device Name: MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: GHH · Hematology
• Decision Date: Apr 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

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

Device Story

Tina-quant® D-Dimer Test System is a particle-enhanced immunoturbidimetric assay. Latex particles coated with monoclonal antibodies against D-Dimer epitope are mixed with patient plasma samples. Antigen-antibody complexes form, increasing sample turbidity. The degree of turbidity is measured to quantify D-Dimer and X-oligomer levels. Used in clinical laboratory settings by trained personnel. Output provides quantitative concentration values used by clinicians to assess fibrin degradation products in plasma. Benefits include standardized, automated measurement of D-Dimer levels for diagnostic support.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance comparisons between the modified device and predicate devices, including measuring range and expected values.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay. Reagents consist of latex particles coated with monoclonal antibodies. Measures turbidity change via optical detection. Compatible with automated clinical chemistry analyzers. Sample types: citrated plasma and Li-heparin plasma. Measuring range: 0.15 - 9.0 µg FEU/ml.

Indications for Use

Indicated for the in vitro quantitative determination of fibrin degradation products, including D-Dimer and X-oligomers, in human plasma samples.

Predicate Devices

• Tina-quant® D-Dimer Test System (K002706)
• Tina-quant® D-Dimer Test System (K011143)

Submission Summary (Full Text)

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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 information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | 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 |
| Device<br>description | The Tina-quant® D-Dimer Test system is a particle enhanced<br>immunoturbidimetric assay. Latex particles are coated with monoclonal<br>antibodies to the D-Dimer epitope. The antigen/antibody complexes produced<br>by the addition of samples containing D-Dimer lead to an increase in<br>turbidity. |
| Intended use | Immunoturbidimetric assay for the in vitro quantitative determination of<br>fibrin degradation products including D-Dimer and X-oligomers in plasma. |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Tina-quant® D-<br>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-dimer<br>on Roche Hitachi<br>(K002706) | Tina-quant® D-dimer<br>on COBAS Integra<br>(K011143) | Tina-quant® D-dimer<br>(Modified Device) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Intended Use | Immunoturbidimetric<br>assay for the in vitro<br>quantitative<br>determination of fibrin<br>degradation products<br>including D-Dimer and<br>X-oligomers. | The cassette COBAS<br>Integra Tina-quant® D-<br>Dimer contains an in<br>vitro diagnostic reagent<br>system intended for use<br>on COBAS Integra<br>systems for the<br>quantitative<br>immunological<br>determination of fibrin<br>degradation products (D-<br>Dimer and X-oligomers)<br>in plasma | Same |
| Method | Particle enhanced<br>Immunoturbidimetric | Same | Same |
| Sample type | Citrated plasma | Same | Citrated plasma<br>Li-heparin plasma |
| Measuring<br>range | 0.15 - 9.0 µg FEU/ml | Same | Same |
| Expected<br>values | < 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 [phone]. 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 [phone] or [phone] 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