CRP-ADVANCE ASSAY, MODELS 250-20, 250-25

K060139 · Diagnostic Chemicals , Ltd. · DCK · Apr 28, 2006 · Immunology

Device Facts

• Record ID: K060139
• Device Name: CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: DCK · Immunology
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.

Device Story

CRP-ADVANCE is an in vitro diagnostic test system for quantitative measurement of C-reactive protein (CRP) in serum. Principle of operation: immunoturbidimetric assay using anti-human CRP mouse antibody-coated latex particles. Sample (serum) mixed with reagent; CRP binds to antibody-coated latex, causing agglutination. Agglutination measured spectrophotometrically; absorbance change proportional to CRP concentration. Used in clinical laboratory settings by trained technicians. Output provides quantitative CRP concentration to assist clinicians in assessing inflammation or tissue necrosis. Benefits include accurate measurement over a wide concentration range.

Clinical Evidence

No clinical studies were performed. Analytical performance was established via bench testing. Precision (within-run CV 1.5-1.9%, total CV 2.3-3.7%), linearity (0.16-360 mg/L), and limit of quantitation (0.16 mg/L) were validated. Method comparison against a predicate device using 40 patient samples showed high correlation (r=0.9999). Interference testing confirmed no significant impact from icterus, lipemia, hemolysis, or ascorbic acid.

Technological Characteristics

Quantitative immuno-agglutination assay. Reagents: R1 (pH 8.5 buffer), R2 (antihuman CRP mouse monoclonal antibody-coated latex, 2 mg/dL). Measurement: Spectrophotometric absorbance change at 570 nm. Platform: Hitachi 911 automated clinical chemistry analyzer. Traceability: ERM 470.

Indications for Use

Indicated for the quantitative determination of C-reactive protein (CRP) in human serum to aid in the detection of inflammation and tissue necrosis. For in vitro diagnostic use by healthcare professionals.

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

Ms. Penny White Regulatory Affairs Coordinator External, Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE C1E 2A6 Canada

APR 2 8 2006

Re: k060139

> Trade/Device Name: CRP-ADVANCE Regulation Number: 21 CFR§866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: March 14, 2006 Received: March 17, 2006

Dear Ms. White:

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 aft 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 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/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. 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): K060139

Device Name: CRP-ADVANCE

Indications For Use:

## For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.

## Identification.

A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.

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

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

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

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

Carol Benson
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

K060139