K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

K023828 · Kamiya Biomedical Co. · DCK · Feb 4, 2003 · Immunology

Device Facts

• Record ID: K023828
• Device Name: K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
• Applicant: Kamiya Biomedical Co.
• Product Code: DCK · Immunology
• Decision Date: Feb 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases. The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay. The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay. The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

Device Story

K-ASSAY® CRP (3) is an in vitro diagnostic reagent for quantitative measurement of C-reactive protein in serum and plasma samples. Operates via immunoturbidimetric assay principle; utilizes specific calibrators (D, E, F) for standardization. Used in clinical laboratory settings by trained personnel. Output is a quantitative CRP concentration value; assists healthcare providers in diagnosing and monitoring inflammatory conditions and tissue injury. Provides clinical benefit through rapid, sensitive assessment of inflammatory status.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical of immunoturbidimetric assays for CRP.

Technological Characteristics

Immunoturbidimetric assay; quantitative measurement of CRP in serum/plasma. Includes multi-calibrators (D, E, F). Standard clinical laboratory reagent format.

Indications for Use

Indicated for quantitative determination of C-reactive protein (CRP) in human serum and plasma to aid in detection and evaluation of tissue injury, inflammatory disorders, and related diseases. No specific age or gender restrictions stated.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Submission Summary (Full Text)

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Image /page/0/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 consists of a stylized human figure with three overlapping profiles, representing health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 0 4 2003

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

Re: k023828

Trade/Device Name: K-Assay® CRP (3) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: January 14, 2003 Received: January 16, 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 Butman

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® CRP (3) Device Name:

## Indications For Use:

The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.

The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <p>Jean Cooper</p> <p>(Division Sign-Off)</p> </div> |
|-----------------------------------------|------------------------------------------------------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023828 |

| Prescription Use | | OR | Over-The-Counter Use |
|----------------------|--|----|----------------------|
| (Per 21 CFR 801.109) | | | |

Optional Format 1-2-96)

CRP (3) 510(k) KAMIYA BIOMEDICAL COMPANY