STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

K022977 · Dade Behring, Inc. · DAP · Nov 27, 2002 · Hematology

Device Facts

• Record ID: K022977
• Device Name: STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
• Applicant: Dade Behring, Inc.
• Product Code: DAP · Hematology
• Decision Date: Nov 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.

Device Story

Stratus® CS D-dimer CalPak is a liquid calibrator consisting of human D-dimer in a buffered bovine protein matrix; packaged in a sealed plastic cartridge. Designed exclusively for use on the Stratus® CS STAT fluorometric analyzer. The device establishes reference points for D-dimer concentration measurements. The analyzer uses these reference points to update calibration curves; recovered values are automatically calculated from stored calibration coefficients after testing. Used in clinical laboratory settings by trained personnel to ensure accurate D-dimer quantification, aiding in the clinical assessment of fibrin degradation products.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid calibrator; buffered bovine protein matrix with human D-dimer, stabilizers, and sodium azide. Form factor: sealed plastic cartridge. Designed for use on Stratus® CS STAT fluorometric analyzer. Calibration involves updating curves using Master lot values.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator to establish reference points for determining D-dimer concentration in human specimens on the Stratus® CS STAT fluorometric analyzer.

Predicate Devices

• VIDAS® D-dimer (DD) Calibrator

Submission Summary (Full Text)

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KO22927

NOV 2 7 2002

## Summary of Safety and Effectiveness Information

Stratus® CS D-dimer CalPak (calibrator)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.

| Submitter's Name: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | September 4, 2002 |
| Name of Product: | Stratus® CS D-dimer CalPak (calibrator) |
| FDA Classification Name: | Calibrator (21 CFR§862.1150); DAP |
| Predicate Device: | VIDAS® D-dimer (DD) Calibrator |
| Device Description: | The Stratus® CS D-dimer CalPak consists of a plastic cartridge<br>(CalPak) containing human D-dimer in a liquid, buffered bovine<br>protein matrix in each of three wells. The CalPak is designed<br>for use only on the Stratus® CS analyzer |
| Intended Use: | The Stratus® CS D-dimer CalPak is an in vitro diagnostic<br>product used to calibrate the Stratus® D-dimer method on the<br>Stratus® CS STAT fluorometric analyzer. |

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### Comparison to Predicate Device:

| | Stratus®CS<br>D-dimer CalPak | VIDAS® D-dimer<br>Calibrator |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Calibration of the Stratus®<br>D-dimer method | Calibration of the VIDAS®<br>D-dimer method |
| Form: | Liquid, stored frozen | Lyophilized |
| Matrix: | Buffered bovine protein<br>matrix with human D-dimer,<br>stabilizers and sodium azide | Lyophilized fibrin degradation<br>product from human plasma<br>with glycine-albumin bovine<br>buffer and sodium azide. |
| Package: | Sealed plastic cartridge for use<br>only on the Stratus® CS analyzer | Vials; 2 mL reconstituted |
| Calibration: | Calibration curve updated for each<br>lot initially, in triplicate and every<br>60 days thereafter using Master lot<br>values. After completion of each test,<br>the recovered values are automatically<br>calculated from the stored calibration<br>coefficients. | One point calibration tested in<br>duplicate, with each Master lot<br>initially by the user. Afterwards,<br>the user recalibrates every 14 days. |

#### Comments on Substantial Equivalence:

Both the Dade Behring Stratus® CS D-dimer CalPak and the VIDAS® D-dimer calibrator products are intended to calibrate their respective closed system methods utilizing similar designs consisting of human blood products in a buffered, bovine protein-based matrix.

### Conclusion:

The Stratus® CS D-dimer CalPak is substantially equivalent in intended use and design to the VIDAS® D-dimer calibrator as noted above.

RM Vaught

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is composed of three curved lines that resemble a bird in flight or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### NOV 2 7 2002

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500. MS 514 P.O. Box 6101 Newark, DE 19714

k022977 · Re:

Trade/Device Name: Stratus® CS D-dimer CalPak (calibrator) Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP; GHH; JIT Dated: October 30, 2002 Received: November 15, 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).

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Page 2 -

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.

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). Other general information on your responsibilities under the Act may be obtained 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

Device Name:

Koza997

Stratus® CS D-dimer CalPak (calibrator)

#### Indications for Use:

The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.

Rm Van ht
Richard M. Wright

ichard M. Vaught Regulatory Affairs and Compliance Manager

September 4, 2002

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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A. Reeves for J. Bautista

Division Division of Clinical 510(k) Number

Prescription Use > (Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)