K-ASSAY LP(A) CONTROLS

K023853 · Kamiya Biomedical Co. · DFC · Dec 13, 2002 · Immunology

Device Facts

• Record ID: K023853
• Device Name: K-ASSAY LP(A) CONTROLS
• Applicant: Kamiya Biomedical Co.
• Product Code: DFC · Immunology
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.

Device Story

K-ASSAY® Lp(a) Controls are quality control materials used in clinical laboratories to monitor the performance and accuracy of Lp(a) immunoturbidimetric assays. The controls are processed and assayed to provide known values, allowing laboratory technicians to verify that the assay system is functioning correctly. By comparing the measured values of the controls against the expected ranges, clinicians ensure the reliability of patient test results. This monitoring process helps maintain diagnostic accuracy for Lp(a) testing, which is relevant for assessing cardiovascular risk.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed quality control material for immunoturbidimetric assays. Formulated for stability and compatibility with Lp(a) test systems.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays in clinical laboratory settings.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is composed of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## EC 1 3 2002

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

Re: k023853 Trade/Device Name: K-ASSAY® Lp(a) Controls Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: November 15, 2002 Received: November 19, 2002

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 (OS) regulation (21 CFR Part 820).

{1}------------------------------------------------

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

{2}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K033853

K-ASSAY® Lp(a) Controls Device Name:

## . Indications For Use:

The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista.

(Division Sign-Off)
Division of Clinical Laboratory Devices K023853
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Optional Format 1-2-96)