ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date "SEP 24 1998". The month is September, the day is the 24th, and the year is 1998. The text is in a bold, sans-serif font. The image is slightly blurry. K 981985 ## 510(k) Summary of Safety and Effectiveness #### 1. General Information Device Generic Name: Device Trade Name: Applicant's Name and Address: Carcinoembryonic Antigen (CEA) Immunological Test System for Management of Cancers ACCESS® CEA Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Date: June 4, 1998 #### 2. Predicate Device Abbott IMx CEA Microparticle Enzyme Immunoassay Abbott Laboratories One Abbott Park Road Abbott Park, IL 60064-3500 PMA Number: P830066 #### 3. Device Description The ACCESS CEA Immunoassay Reagents and the ACCESS Immunoassay Analyzer comprise the ACCESS Immunoassay System for the quantitative determination of CEA in human serum. #### 4. Indications for Use The ACCESS CEA Immunoassay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen (CEA) in human serum using the ACCESS Immunoassay System. CEA, measured by the ACCESS CEA Immunoassay, is intended for use as an aid in the management of cancer patients. #### 5. Comparison of Technological Characteristics Both the ACCESS CEA Immunoassay and the Abbott IMx CEA assay quantitatively measure serum CEA by means of simultaneous immunoassays utilizing the binding of CEA to monoclonal antibodies specific to epitopes on the CEA molecule. Both systems utilize liquid multi-point calibrators. The ACCESS CEA Immunoassay Reagents are designed for use on the ACCESS Immunoassay Analyzer, a fully automated random access system, with up to 24 different reagents on board. The Abbott IMx Immunoanalyzer is an automated batch mode system in which a single analyte is assaved at one time. The ACCESS Immunoassay Analyzer uses magnetic particle solid phase enzyme immunoassays with chemiluminescent measurement, while the Abbott IMx CEA Immunoassay uses a glass-fiber matrix as the solid phase with a fluorescent detection method. #### 6. Summary of Studies Correlation: A comparison of CEA values from 146 samples, ranging from 0 to 1000 ng/ml, run with both the ACCESS CEA Immunoassay and the Abbott IMx CEA Immunoassay demonstrated very good agreement with the following statistical data: r = 0.97; y = 1.02x + 1.76. Expected Range: In a population of 234 apparently healthy males and females, 98.7% had CEA values of 5.0 ng/ml or less, with the remaining 1.3% having values in the 5.1 to 10.0 nq/ml range. {1}------------------------------------------------ Monitoring Data: Longitudinal serum samples from previously diagnosed cancer patients were compared using the ACCESS CEA and IMx CEA assays. The monitoring patient data demonstrate that the Access CEA results are highly concordant to both the IMx CEA results and the concurrent clinical assessments. Recovery: Linearity studies performed by diluting human serum samples with ACCESS CEA Sample Diluent provided an average recovery of 99.9%, with sample mean recoveries ranging from 91.1 to 109.1%. Recovery of exogenous CEA spiked into serum samples resulted in an overall mean recovery of 103.0%, with mean recoveries ranging from 99.0 to 106.2%. Precision: Within-run, between-run and total imprecision of the Access CEA immunoassay were less than 5% when tested at concentrations between 5.0 and 500 ng/ml. Specificity: There was no significant interference from CEA-like antigens (NCA, NCA-2. NCA-50 and NFA-1), potential sample contaminants (albumin, bilirubin, HAMA, hemoglobin, lipemia and rheumatoid factor), and therapeutic agents (bleomycin-, cisplatin, cyclophosphamide, doxorubicin, fluorouracil, leucovorin, methotrexate, mitomycin, tamoxifen, vinblastine, and vincristine). Hook Effect: There was no hook effect observed at CEA concentrations up to 100,000 ng/ml. Analytical Sensitivity: The lowest level of detection of CEA distinguishable from zero (ACCESS CEA Calibrator S0) with 95% confidence is 0.1 ng/ml. #### 7. Conclusion The ACCESS CEA Immunoassay Reagents, when used in conjunction with the ACCESS Immunoassay Analyzer, are substantially equivalent to the Abbott IMx CEA Immunoassay. The ACCESS CEA Immunoassay is appropriate for monitoring patients with cancer. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle. # SEP 2 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Ellen Voss Regulatory Affairs Beckman Coulter 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084 Re: K981985/S1 Trade Name: ACCESS® CEA Assay Regulatory Class: II Product Code: DHX Dated: July 31, 1998 Received: July 31, 1998 Dear Ms. Voss : ....... 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. the country of the same 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 Requlations, 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 themact = " for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ### 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 leqally 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 "ram address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Gutman 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 _________________________________________________________________________________________________________________________________________________________________________ 1 of of 1 510(k) Number (if known): Device Name: ACCESS® CEA ### Indications For Use: The Access® CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic antigen (CEA) in human serum using the ACCESS Immunoassay System. CEA measured by the Access CEA Immunoassay, is used as an aid in the management of cancer patients. (PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Peter E. Malm (Division Sign Division of Clinical Laboratory De 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)