WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET

K024280 · Wako Chemicals USA, Inc. · DCK · Jun 6, 2003 · Immunology

Device Facts

• Record ID: K024280
• Device Name: WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
• Applicant: Wako Chemicals USA, Inc.
• Product Code: DCK · Immunology
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The Wako CRP test is an in vitro assay for the quantitative determination of C-reactive protein in serum.

Device Story

Wako CRP is an in vitro diagnostic turbidimetric immunoassay for measuring C-reactive protein (CRP) in serum. The device utilizes a buffer and goat anti-human CRP antibody reagent; when mixed with a patient serum sample, CRP binds to the antibody to form insoluble aggregates. This reaction increases solution turbidity, which is measured optically. The degree of turbidity is directly proportional to the CRP concentration in the sample. The test is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in detecting inflammation, infection, and assessing tissue injury. The system includes specific calibrators (Wako CRP Calibrator and Calibrator Set) to ensure quantitative accuracy.

Clinical Evidence

Bench testing only. Precision studies demonstrated acceptable day-to-day performance. The method has a minimum detectable level of 1 mg/L and linearity up to 230 mg/L (with Wako CRP Calibrator Set) or 200 mg/L (with Wako single point CRP Calibrator).

Technological Characteristics

Turbidimetric immunoassay; reagents include buffer and goat anti-human CRP antibody; optical measurement of turbidity; linearity up to 250 mg/L; in vitro diagnostic use.

Indications for Use

Indicated for the quantitative determination of C-reactive protein (CRP) in serum to aid in the evaluation of tissue injury, inflammation, and infection in patients.

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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KO24280

Wako Chemicals USA. Inc. 1600 Bellwood Road, Richmond, VA 23

## 510(K) Summary of Safety and Effectiveness

### Intended use

The Wako CRP test is an in vitro assay for the quantitative determination of C-reactive protein in serum.

## Summary and explanation of the test

A protein that binds the C-polysaccharide on the cell wall of Streptococcus pneumoniae presents in the sera of acutely ill patients. This protein is called C-reactive protein (CRP), which has been recognized as one of the acute phase reactants that rise dramatically in the case of inflammation or tissue destruction. Determination of CRP is clinically useful for detecting. inflammation and infections. Various methods can be used for the determination of CRP (e.g. turbidimetric immunoassay (TIA), nephelometric immunoassay (NIA) and latex immunoassay (LIA). The Wako CRP test is a highly specific reagent based on turbidimetric immunoassay. 12 The Wako CRP test with one -point calibration shows the linearity up to 150 mg/L. The Wako CRP test with multi-point calibrations shows the linearity up to the highest value of calibrator set (more than 250 mg/L).

## Principle of the method

When a sample is mixed with Buffer and Antibody, CRP in the sample combines specifically with anti-human CRP antibody (goat) in the Antibody to yield an insoluble aggregate that causes increased turbidity in the solution. The degree of turbidity of solution can be measured optically and is proportional to the concentration of CRP in the patient's sample.

Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1 mg/L . The assay is lincar to 230 mg/L when using the Wako CRP Calibrator Sct and 200 mg/L when using the Wako single point CRP Calibrator.

#### References

Burtis, C. A. and Ashwood, E. R., Ed .: Tietz Textbook of Clinical Chemistry, 2nd Ed., Saunders, Philadelphia, 1994.

Lothar Thomas, M.D., Ed .: Clinical Laboratory Diagnostics

DG Klinische Chemic Mitteilungen 26 (1995) page5.

Tracy RP, Lemaltro RN, Peaty BM, Ives DG, Evans RW, Cushman M, Mellahn EN, Kuller LH, Rclationship of C-reactive protein to risk of cardiovascular disease in the elderly; results from the Cardiovascular Health Study and the Rural Hearth Promotion Project. Arterioscler Thrombo Vaso Biol, 1997; 17:1121-1127

Tuzallallum
Tonya Mallory Executive Manager

April 7, 2003

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 6 2003

Ms. Tonya Mallory Executive Manager Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

k024280 Re:

> Trade/Device Name: Wako CRP, Wako CRP Calibrator and Wako CRP Calibrator Set Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK; JIT; JJX Dated: March 31, 2003 Received: April 1, 2003

Dear Ms. Mallorv:

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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## 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). 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:

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

The Wako CRP Calibrator and Wako CRP Calibrator Sct are designed to be used with the Wako CRP test for the determination of the C-Reactive protein in serum.

Proprietary Name: Wako CRP, Wako CRP Calibrator and Wako CRP Calibrator Set

| Establishment Registration Number: | 1627434 |
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| Premarket Notification 510(k) Number: | K024280 |

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

Concurrence of CDRH, ODE

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use (Optional Format 1-2-96)

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 0.24280