K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B

K992312 · Kamiya Biomedical Co. · DCK · Sep 13, 1999 · Immunology

Device Facts

• Record ID: K992312
• Device Name: K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
• Applicant: Kamiya Biomedical Co.
• Product Code: DCK · Immunology
• Decision Date: Sep 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The K-ASSAY CRP (2) Assay is intended to be used for the quantitative determination of CRP in serum by latex particle enhanced immunoturbidimetric assay. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues. The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (2) Assay. The K-ASSAY CRP Multi-Calibrator B is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.

Device Story

K-ASSAY CRP (2) is an in vitro diagnostic reagent kit for quantitative measurement of C-Reactive Protein (CRP) in serum. It utilizes a latex particle-enhanced immunoturbidimetric assay principle. The device is used in clinical laboratory settings by trained laboratory personnel. The assay measures turbidity changes resulting from antigen-antibody reactions between CRP in the patient sample and anti-CRP antibody-coated latex particles. Results are used by clinicians to assess the extent of tissue injury or inflammation. The system includes multi-calibrators (A and B) to ensure accurate quantification. The device provides objective data to support clinical decision-making regarding patient inflammatory status.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the analytical performance of the immunoturbidimetric assay.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay; utilizes anti-CRP antibody-coated latex particles; quantitative serum analysis; requires external calibration via provided multi-calibrators.

Indications for Use

Indicated for the quantitative determination of C-Reactive Protein (CRP) in human serum to aid in the evaluation of tissue injury. Intended for prescription use.

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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SEP 1 3 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

Re: K992312

> Trade Name: K-ASSAY CRP (2), K-ASSAY CRP Multi-Calibrator A, K-ASSAY CRP Multi-Calibrator C

Regulatory Class: II Product Code: DCK Dated: July 7, 1999 Received: July 9, 1999

Dear Mr. Getty:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 comply 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 predicate 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Dutman

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): K992312

K-ASSAY CRP (2) Device Name:

## Indications For Use:

CRP (2) 510(k)

The K-ASSAY CRP (2) Assay is intended to be used for the quantitative determination of CRP in serum by latex particle enhanced immunoturbidimetric assay. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues.

The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.

The K-ASSAY CRP Multi-Calibrator B is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K992312 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

Optional Format 1-2-96)ಟ

6/21/99