K-ASSAY D-DIMER CONTROLS

K012422 · Kamiya Biomedical Co. · GGC · Aug 21, 2001 · Hematology

Device Facts

• Record ID: K012422
• Device Name: K-ASSAY D-DIMER CONTROLS
• Applicant: Kamiya Biomedical Co.
• Product Code: GGC · Hematology
• Decision Date: Aug 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.

Device Story

K-ASSAY D-Dimer Controls serve as quality control samples for D-Dimer immunoturbidimetric assays. The device provides a consistent test sample with a known concentration of D-Dimer. Laboratory personnel use these controls to monitor assay performance, ensuring accuracy and reliability of patient test results. The controls are intended for professional use in clinical laboratories.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic control material; liquid or lyophilized form; designed for use with immunoturbidimetric D-Dimer assays; non-sterile; no specific materials or software algorithms described.

Indications for Use

Indicated for use as a quality control material to monitor the performance of D-Dimer immunoturbidimetric assays in clinical laboratory settings.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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AUG 2 1 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Don Tran Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

Re: K012422 Trade Name: K-ASSAY D-Dimer Controls Regulation Number: 21 CFR § 864.5425 Regulatory Class: II Product Code: GGC Dated: July 20, 2001 Received: July 30, 2001

Dear Mr. Tran:

We have reviewed your Section 510(k) notification of intent to market the device referenced wo have and we have determined the device is substantially equivalent (for the indications for use above and we nave active actived 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). You may, therefore, market the device, subject to the general controls Cosmono rice (110). - The general controls provisions of the Act include requirements for annual provisions of the reason and acturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Femanson up vice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noalicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionifacturers 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 Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K-ASSAY D-Dimer Controls Device Name:

Indications For Use:

As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.

Josephine Bautista

y Devices

510(k) Number K014422

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)