STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D

K022976 · Dade Behring, Inc. · DAP · Jan 16, 2003 · Hematology

Device Facts

• Record ID: K022976
• Device Name: STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
• Applicant: Dade Behring, Inc.
• Product Code: DAP · Hematology
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

The Dade Behring Stratus® CS D-dimer method is an in vitro diagnostic test intended for use with the Stratus® CS fluorometric analyzer for the determination of cross-linked fibrin degradation products (D-dimer) in plasma.

Device Story

The Dade Behring Stratus® CS D-dimer method is an enzyme-linked fluorescent immunoassay used for the quantitative measurement of D-dimer in human plasma. The device utilizes a five-well plastic cartridge (TestPak) containing embedded glass fiber paper. Reagents and patient plasma samples are added to the cartridge; the device measures the enzymatic rate of the bound D-dimer fraction via fluorescence. The analyzer performs all data analysis automatically. It is intended for clinical laboratory use to aid in the assessment of fibrin degradation. By providing quantitative D-dimer levels, the device assists healthcare providers in evaluating patients for conditions involving fibrinolysis.

Clinical Evidence

Clinical performance was evaluated via a split-sample comparison study using 123 patient plasma samples. The Stratus® D-dimer method was compared against the VIDAS® D-dimer assay. Results showed a correlation coefficient of 0.923, a slope of 0.995, and an intercept of 159 ng/mL, with sample concentrations ranging from 79 ng/mL to 5689 ng/mL.

Technological Characteristics

Automated fluorescent immunoassay; 450nm excitation/emission. Reagents: alkaline phosphatase conjugate, 4-methylumbelliferyl phosphate substrate. Form factor: five-well plastic TestPak cartridge with embedded glass fiber paper. Connectivity: integrated with Stratus® CS fluorometric analyzer. Calibration: lot-specific curve updated every 60 days.

Indications for Use

Indicated for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma using the Stratus® CS fluorometric analyzer.

Predicate Devices

• bioMerieux Vitek VIDAS® D-dimer Assay (K973819)

Submission Summary (Full Text)

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1022976

# JAN 1 6 2003

# Summary of Safety and Effectiveness Information

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.

| Submitter's Name: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
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| Date of Preparation: | September 4, 2002 |
| Name of Product: | Dade Behring Stratus® CS D-dimer method; includes separately<br>supplied TestPak (assay) and DilPak (diluent) |
| FDA Classification Name: | Fibrinogen/fibrin degradation products assay |
| Predicate Device: | bioMerieux Vitek VIDAS® D-dimer Assay (K973819) |
| Device Description: | The Dade Behring Stratus® CS D-dimer TestPak method is an enzyme-linked fluorescent immunoassay that consists of a five(5)- well, plastic cartridge (TestPak) designed for use only on the Dade Behring Stratus® CS fluorometric analyzer. Within the TestPak cartridge is a small square of embedded glass fiber paper. Reagents and sample are added through an opening onto the glass fiber paper. Following incubation, the enzyme-labeled antibody and the bound D-dimer fraction react. The enzymatic rate of the bound fraction increases with the concentration of the D-dimer in the sample and is measured via fluorescence. Dilutions, if needed, may be accomplished via utilization of the Stratus®CS DilPak |

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(diluent) cartridges. All data analysis functions are performed automatically by the analyzer. The Dade Behring Stratus® CS D-dimer method is an in vitro Intended Use: diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus® CS D-dimer method is substantially equivalent Comparison to Predicate Device: in technological design and intended use to other D-dimer assays such as the bioMerieux Vitek VIDAS® D-dimer assay (K973819). A comparison of the features of these products is provided below:

| Feature | Dade Behring Stratus® CS<br>D-dimer Method | bioMerieux Vitek VIDAS®<br>D-dimer Assay |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | in vitro use | in vitro use |
| Technology: | Automated<br>Fluorescent immunoassay; 450nm<br>Alkaline phosphatase = conjugate<br>4-methylumbelliferyl phosphate = substrate | Automated<br>Fluorescent immunoassay; 450 nm<br>Alkaline phosphatase = conjugate<br>4-methylumbelliferyl phosphate = substrate |
| Sample: | whole blood/plasma | plasma |
| Sample volume: | 75 uL | 200 uL |
| Assay range: | 6 - 5000 ng/mL | 45 - 1000 ng/mL |
| Calibration: | Calibration curve updated for each lot,<br>using one level (triplicate) and every<br>60 days, thereafter. After calibration<br>update at completion of each test, recovered<br>values are calculated from stored calibration<br>coefficients. | One point calibrator tested (duplicate) with each<br>lot initially and every 14 days, thereafter. |

#### Comments on Substantial Equivalence:

Split sample comparison with citrated human plasma samples between the Stratus® D-dimer method and the VIDAS® D-dimer (DD) assay gave a correlation coefficient of 0.923, a slope of 0.995 and an intercept of 159 ng/mL. In this study, clinical patient

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samples (n = 123) were tested at Dade Behring (Glasgow, Delaware) and ranged from 79 ng/mL to 5689 ng/mL as tested on the VIDAS® D-dimer assay.

#### Conclusion:

The Dade Behring Stratus® CS D-dimer (DDMR) method and the bioMerieux Vitek VIDAS® Ddimer (DD) assay are substantially equivalent in intended use, technological design and specific performance characteristics, including split sample comparison results as noted above.

KimVaught

Richard M. Vaught Regulatory Affairs and Compliance Manager September 4, 2002

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site, Bldg. 500, Box 514 P.O. Box 6101 Newark, Delaware 19714-6101

JAN 1 6 2003

k022976 Re:

> Trade/Device Name: Stratus® CS D-dimer (DDMR) Method Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrin Degradation Products Regulatory Class: II Product Code: DAP Dated: December 18, 2002 Received: December 20, 2002

Dear Mr. Vaught:

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 vours,

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

Device Name:

K022976

Stratus® CS D-dimer (DDMR) Method

Indications for Use:

The Dade Behring Stratus® CS D-dimer method is an in vitro diagnostic test intended for use with the Stratus® CS fluorometric analyzer for the determination of cross-linked fibrin degradation products (D-dimer) in plasma.

Rmplinight

chard M. Vaught Regulatory Affairs and Compliance Manager

September 4, 2002

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jacchini Bautista

(Division Sin-Off)
Division of clinical Laboratory Devices
510(k) Number K022976

Prescription Use (Per 21 CFR 801.109)

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OR

Over-the-counter Use

(Optional format 1-2-96)