K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

K030687 · Kamiya Biomedical Co. · DAP · Jun 27, 2003 · Hematology

Device Facts

• Record ID: K030687
• Device Name: K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
• Applicant: Kamiya Biomedical Co.
• Product Code: DAP · Hematology
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay. The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay. For in vitro diagnostic use.

Device Story

The K-ASSAY® D-Dimer system is an in vitro diagnostic reagent kit used for the quantitative measurement of D-Dimer in human plasma or serum samples. The device utilizes an immunoturbidimetric assay principle, where specific antibodies react with D-Dimer in the sample to form antigen-antibody complexes, resulting in turbidity changes measured by a clinical chemistry analyzer. The system includes a calibrator set for assay standardization. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a quantitative concentration value of D-Dimer, which assists clinicians in the assessment of fibrinolytic activity and the diagnosis of conditions associated with fibrin degradation. The device provides a standardized method for monitoring D-Dimer levels to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Immunoturbidimetric assay; utilizes specific antibodies for D-Dimer detection; quantitative measurement via turbidity change; intended for use on clinical chemistry analyzers; in vitro diagnostic reagent; includes calibrator set.

Indications for Use

Indicated for the quantitative determination of cross-linked fibrin degradation products (D-Dimer) in human plasma or serum. For in vitro diagnostic use by prescription.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 7 2003

Mr. Brian Schliesman Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, WA 98188

Re: k030687

Trade/Device Name: K-Assay® D-Dimer Immunoturbidimetric Assay and K-Assay® D-Dimer Immunoturbidimetric Calibrator Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP: GHH Dated: June 5, 2003 Received: June 5, 2003

Dear Mr. Schliesman:

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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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). 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): ____________________________________________________________________________________________________________________________________________________

K-ASSAY® D-Dimer Immunoturbidimetric Assay and Device Name: K-ASSAY® D-Dimer Calibrator

Indications For Use:

The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.

The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay.

For in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division Diagnostic Device of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
In September of Sefety Office of in and Safety
Evaluation and Safety

510(k) K030687

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Optional Format 1-2-96)