OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT

K041668 · Olympus America, Inc. · NQD · Aug 19, 2004 · Immunology

Device Facts

• Record ID: K041668
• Device Name: OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
• Applicant: Olympus America, Inc.
• Product Code: NQD · Immunology
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

System reagent for the quantitative determination of C-Reactive Protein in human serum on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Device Story

Olympus CRP Latex Immunoturbidimetric Reagent is an in vitro diagnostic reagent for use on Olympus clinical chemistry analyzers. The device utilizes latex-enhanced immunoturbidimetric technology to measure C-Reactive Protein (CRP) levels in human serum samples. The reagent is intended for use by clinical laboratory professionals to assist in the diagnosis and management of inflammatory conditions and cardiovascular risk assessment. The analyzer measures the turbidity change resulting from the antigen-antibody reaction between CRP in the patient sample and anti-CRP antibodies coated on latex particles. The resulting quantitative output is used by clinicians to evaluate infection, tissue injury, and inflammatory states, or to assess prognosis in patients with coronary artery disease.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance characteristics and technological similarity to existing predicate devices.

Technological Characteristics

Latex-enhanced immunoturbidimetric reagent; liquid-stable formulation; designed for use on automated Olympus clinical chemistry analyzers; utilizes antigen-antibody reaction principle; quantitative measurement via turbidimetry.

Indications for Use

Indicated for quantitative determination of C-Reactive Protein (CRP) in human serum. Used for detection/evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Also used as an aid in identifying individuals at risk for future cardiovascular disease and as a prognostic marker for recurrent events in patients with stable coronary disease or acute coronary syndromes.

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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 9 2004

Mr. Michael Campbell Senior Manager, RA/QA Olympus America Inc. 3131 West Royal Lane Irving, Texas 75063-3104

k041668 Re:

Trade/Device Name: Olympus CRP Latex Immunoturbidimetric Reagent Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: June 17, 2004 Received: June 18, 2004

Dear Mr. Campbell:

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,

Seain M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | K041668 |
|---------------------------|-----------------------------------------------|
| Device Name: | Olympus CRP Latex Immunoturbidimetric Reagent |

Indications For Use:

System reagent for the quantitative determination of C-Reactive Protein in human serum on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of in Vitro Diagnos Device Evaluation and

510(k) K041168

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