CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

{0}------------------------------------------------ **JUN 13 2002** # 510(k) Summary Safety and Effectiveness "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.922 | | CRPex-HS C-Reactive Protein LIT Assay | |---------------------|---------------------------------------------------------------------| | Submitter | | | Name, | Good Biotech Corp. | | Address, | 38 34th Rd. Taichung Industrial Park Taichung City 407 Taiwan | | | R.O.C. | | Telephone number, | +886-4-23596873 | | Contact person, | Victor Chiou | | Preparation date | Feburary 21, 2002 | | Device | | | Trade name, | CRPex-HS C-reactive protein LIT assay | | Common name, | CRP immunological diagnostic assay | | Classification name | C-reactive protein immunological test system (21CFR 866.5270) | | Predicate Device | | | Trade name, | Wako CRP-UL | | 510(k) number | K003342 | | | | | Description | | | | CRPex-HS C-reactive protein LIT assay is the ready-to-use reagent | | | suitable for quantification of C-reactive protein by latex particle | | | enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is | | | coupled to polystyrene microparticles, which greatly increased the | hs-CRP assay for CRP quantification in the lower range. analytical sensitivity. CRPex-HS C-reactive protein LIT assay is a {1}------------------------------------------------ #### Intended Use Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use. : #### Substantial Equivalence CRPex-HS C-reactive protein LIT assay is compared with Wako CRP-UL to demonstrate the substantial equivalence. 2008年07月15日 日本 2004年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1 | Item Device | CRPex-HS<br>C-reactive LIT assay | Wako CRP-UL | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Measurement of<br>C-reactive protein is<br>useful for the detection<br>and evaluation of<br>infection, tissue injury,<br>inflammatory disorders<br>and associated diseases. | Measurement of<br>C-reactive protein is<br>useful for the detection<br>and evaluation of<br>infection, tissue injury,<br>inflammatory disorders<br>and associated diseases. | | Methodology | Latex particle enhanced<br>immunoturbidimetry | Latex particle enhanced<br>immunoturbidimetry | | Test Objective | C-reactive protein | C-reactive protein | | Test Principle | Latex microparticle<br>agglutination based on<br>antigen-antibody reaction. | Latex microparticle<br>agglutination based on<br>antigen-antibody reaction. | | Type of Test | Quantitative | Quantitative | | Product Type | Reagent 1 (R 1):<br>Reactive buffer solution<br>Reagent 2 (R 2):<br>Latex suspension | Buffer:<br>Reactive buffer solution<br>Latex reagent:<br>Latex suspension<br>Diluent:<br>Sample diluent | • ﺷ {2}------------------------------------------------ | Antibody<br>(Source) | Duck anti-CRP IgY(AFc)<br>(Egg Yolk) | Goat anti-CRP antibodies<br>Serum | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Sterility | N.A. | N.A. | | Stability | 2-10 °C<br>Opened: 1 month | 2-10 °C<br>Opened: 1 month | | Specimen | Human serum | Human serum | | Operating<br>Requirement | For professional use only | For professional use only | | Calibration Mode | Spline | Spline | | Calibrator | Wako CRP-UL Calibrator | Wako CRP-UL Calibrator | | | Set (5 concentrations) | Set (5 concentrations) | | Sample Volume | 8 ul/test | 3 (6) ul/test | | Reagent Volume | R1:120 µl/test | R1:270 ul/test | | | R2:120 ul/test | R2:60 µl/test | | Wavelength<br>Selection | Main-wavelength:570 nm<br>Sub-wavelength: 800 nm | Main-wavelength:700 nm | | Assav Code<br>【Hitachi 717 (7150)】 | 2 point:<br>(27)-(33) | 2 point:<br>(28)-(50) | | Assay Range | 0.05-20 mg/L | 0.1-10 mg/L (sample<br>volume= 3 ul)<br>0.05-5 mg/L (sample<br>volume= 6 ul) | | Calibration Curve | Nearly linear | Nearly linear | | Interference | Bilirubin:<br>up to 45 mg/dl<br>unconjugated bilirubin<br>Hemolysis:<br>up to 800-mg/dl<br>hemoglobin<br>Lipemia:<br>up to 10 g/L Liposyn®<br>(fat emulsion) | Ascorbic acid:<br>up to 50 mg/L<br>Free bilirubin:<br>up to 50 mg/dl<br>Hemoglobin:<br>up to 500 mg/dl<br>Intrafat:<br>up to 5.0 % | : E-3 i ﺘﺮ {3}------------------------------------------------ # Correlation y=0.9293x + 0.169 x=Wako CRP-UL y= CRPex-HS C-reactive protein LIT assay R2=0.991 N=141 ### Conclusion Good Biotech Corp.'s CRPex-HS C-reactive protein LIT assay is substantially equivalent to the predicate device Wako CRP-UL. ﺷ {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing human profiles or a stylized bird. JUN 1 3 2002 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Victor Chiou President Good Biotech Corp. 38 34th Road Taichung Industrial Park Taichung 407 Taiwan R. O. C. > k020603 Trade/Device Name: CRPex-HS C-reactive protein LIT assay Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: May 9, 2002 Received: May 9, 2002 Dear Mr. Chiou: Re: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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 {6}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE # 510(k) Number (if known): KO:λΟζΟζΟ Device Name: CRPex-HS C-reactive protein LIT assay #### Indications For Use: Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For In Vitro Diagnostic Use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sean Cooper (Division Sign-Off) sion of Clinica 510(k) Number Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96) OR