ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT

{0}------------------------------------------------ 5/3/99 90704 Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized circular graphic to the left of the company name, which is written in a bold, sans-serif font. The word "BECKMAN" is placed above the word "COULTER". The logo is black and white. Summary of Safety & Effectiveness Array® 360 System C-Reactive Protein (CRPMPE) Reagent ## 1.0 Submitted By: Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123 ### 2.0 Date Submitted: March 3, 1999 ### 3.0 Device Name(s): # 3.1 Proprietary Names Array® 360 System C-Reactive Protein (CRPMPE) Reagent #### 3.2 Classification Name C-Reactive Protein immunological test system (21 CFR § 866.5270) # 4.0 Predicate Device(s): | | Predicate | Manufacturer | Docket<br>Number | |--------------------------------------------------------------|-------------------------------------------------------|-----------------------|------------------| | Array® 360 System C-<br>Reactive Protein<br>(CRPMPE) Reagent | IMMAGE System C-<br>Reactive Protein (CRP)<br>Reagent | Beckman Coulter, Inc. | K981638 | #### 5.0 Description: The Array 360 System (CRPMPE) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman Coulter's Array 360 System. #### 6.0 Intended Use: C-Reactive Protein (CRPME) Reagent, when used in conjunction with Beckman Coulter's Array® 360 System and Calibrator 5 Plus, is intended for the quantitative determination of human C-reactive protein in serum or plasma by rate nephelometry. Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000 Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com {1}------------------------------------------------ # Comparison to Predicate(s): 7.0 The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. | | SIMILARITIES | | |------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Array 360 System<br>CRPMPE Reagent | Intended use | Same as IMMAGE System CRP<br>Reagent | | | Nephelometric principle | | | | Latex coated particles | | | | Shelf-life of 24 months<br>(stored at 2-8°C) | | | | Calibrator<br>(Calibrator 5 Plus) | | | | DIFFERENCES | | | Array 360 System<br>CRPMPE Reagent | Angle of measurement | The Array 360 System measures at a<br>70° angle while the IMMAGE System<br>measures at a 90° angle | | | Initial analytic range | The initial analytic range for the Array<br>360 is 0.1 - 12.0 mg/dL while the<br>IMMAGE System is 0.1 - 8.0 mg/dL. | | | Reaction temperature | The Array 360 System measure at<br>26.7°C while the IMMAGE System<br>measures at 37°C. | ### Summary of Performance Data: 8.0 The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments. # Method Comparison Study Results | Test Method | Sample Type | Slope | Intercept | r | n | Predicate Method | |---------------------|-------------|-------|-----------|-------|-----|------------------| | Array 360<br>CRPMPE | serum | 0.983 | 0.072 | 0.995 | 180 | IMMAGE CRP | | Estimated Imprecision | | | | | |------------------------|--------------|--------------|-------|----| | Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N | | Within-Run Imprecision | | | | | | Level 1 | 0.27 | 0.027 | 10.1 | 80 | | Level 2 | 6.92 | 0.143 | 2.1 | 80 | | Level 3 | 10.9 | 0.37 | 3.4 | 80 | | Total Imprecision | | | | | | Level 1 | 0.27 | 0.038 | 13.9 | 80 | | Level 2 | 6.92 | 0.248 | 3.6 | 80 | | Level 3 | 10.9 | 0.52 | 4.8 | 80 | # Estimated Imprecision This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. Beckman Coulter, Inc., Section 510(k) Notification Array® 360 System C-Reactive Protein (CRPMPE) Reagent Summary of Safety & Effectiveness file: crpmpe510k.sse {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. 3 1959 MAY Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000 K990704 Re: Trade Name: Array® 360 System C-Reactive Protein (CRPMPE) Reagent Regulatory Class: II Product Code: DCK Dated: March 3, 1999 Received: March 4, 1999 Dear Ms. Hellie: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman 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 {4}------------------------------------------------ page ___ of __________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): K 990704 Device Name: Array® 360 System C-Reactive Protein (CRPMPE) Reagent Indications for Use: C-Reactive Protein (CRPME) Reagent, when used in conjunction with Beckman Coulter's Array® 360 System and Calibrator 5 Plus, is intended for the quantitative determination of human C-reactive protein in serum or plasma by rate nephelometry. Clinical Significance: Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH/Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K990704 Prescription Use (per 21 CFR 801.109) OR Over-the-Counter Use Optional Format 1-2-96