OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH

K051564 · Olympus America, Inc. · NQD · Aug 22, 2005 · Immunology

Device Facts

• Record ID: K051564
• Device Name: OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
• Applicant: Olympus America, Inc.
• Product Code: NQD · Immunology
• Decision Date: Aug 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Olympus System Reagent and calibrators for the quantitative determination of C-Reactive Protein in human serum and plasma 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 of future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, maybe 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 and Calibrators are in vitro diagnostic reagents used on Olympus Analyzers. The device utilizes latex-enhanced immunoturbidimetric technology to measure C-Reactive Protein (CRP) levels in human serum or plasma samples. The principle of operation involves an antigen-antibody reaction between CRP in the patient sample and anti-CRP antibodies coated on latex particles, resulting in turbidity proportional to the CRP concentration. The analyzer measures this turbidity to provide a quantitative result. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing inflammatory conditions, evaluating tissue injury/infection, and assessing cardiovascular risk. The device provides objective data to support clinical decision-making regarding patient prognosis and management of coronary syndromes.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics typical of immunoturbidimetric reagent systems.

Technological Characteristics

Reagent: latex particles coated with rabbit anti-CRP antibodies. Calibrators: liquid human serum-based, 5-level set. Measurement: immunoturbidimetric (light scatter/absorbance). Energy: optical (turbidimetry). Connectivity: integrated with Olympus AU-series clinical chemistry analyzers. Sterilization: N/A (reagent). Software: embedded analyzer firmware for data processing and concentration calculation.

Indications for Use

Indicated for quantitative determination of C-Reactive Protein in human serum and plasma for detection/evaluation of infection, tissue injury, inflammatory disorders, and cardiovascular disease risk assessment. Used as 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 2 2005

Ms. Bev Harding RA Analyst Olympus America Inc. 3131 West Royal Lane Irving, Texas 75063-3104

Re: k051564

Trade/Device Name: Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD, JIT Dated: June 13, 2005 Received: June 14, 2005

Dear Ms. Harding:

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) I ms letter will anow you to ough mating of substantial equivalence of your device to a legally premarked 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, rr you destre spothing michiance as betising of your device, please contact the Office of In or quotions on c. 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 Tou may other 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/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting 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):

## Olympus CRP Latex Immunoturbidimetric Reagent and Device Name: Calibrators

Indications for Use:

..

Olympus System Reagent and calibrators for the quantitative determination of C-Reactive Protein in human serum and plasma 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 of future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, maybe useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

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

CAC
(Division Sign/Off)

Division of Clinical Laboratory Devices 510(k) Number