← Product Code [LTK](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK) · K964185 # IMX CA 125 (K964185) _Abbott Diagnostics · LTK · Nov 4, 1997 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK/K964185 ## Device Facts - **Applicant:** Abbott Diagnostics - **Product Code:** [LTK](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK.md) - **Decision Date:** Nov 4, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.6010 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The IMx® CA 125™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 125 assay values in human serum. The IMx® CA 125™ assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. ## Device Story IMx CA 125 is a microparticle enzyme immunoassay (MEIA) used for quantitative measurement of CA 125 in human serum. Device operates on the IMx System; utilizes Abbott calibrators and controls. Used in clinical laboratory settings to monitor therapy response in epithelial ovarian cancer patients. Healthcare providers use serial CA 125 measurements in conjunction with other clinical methods to track disease status. Benefits include objective monitoring of treatment efficacy and patient clinical status. ## Clinical Evidence Clinical validation included 493 specimens for linear regression analysis (r=0.997). ROC analysis performed on 130 healthy females, 45 patients with benign gynecologic conditions, and 197 ovarian cancer patients. Sensitivity/specificity at 35 U/mL cutoff: 64.0%/96.0% for IMx CA 125 vs 66.0%/92.0% for predicate. Concordance across 542 subjects was 94.1%. Serial tracking data on 55 ovarian cancer patients showed comparable results to predicate and agreement with clinical status in 39 patients. ## Technological Characteristics Microparticle enzyme immunoassay (MEIA) technology. Quantitative measurement of CA 125 in human serum. Dynamic range 0-600 U/mL; sensitivity 2 U/mL. System-based assay utilizing microparticles for signal generation. ## Regulatory Identification A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease. ## Special Controls *Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards. ## Predicate Devices - ABBOTT CA 125 II™ RIA assay ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} NOV - 4 1999 K964185 # 510(k) SUMMARY IMx® CA 125™ ## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION The following information as presented in the Premarket Notification [510(k)] for IMx CA 125 constitutes data supporting a substantially equivalent determination. IMx CA 125 is a microparticle enzyme immunoassay on the IMx System for the quantitative measurement of CA 125 assay values in human serum. IMx CA 125 employs Abbott Calibrators and Controls. Substantial equivalence has been demonstrated between the Abbott IMx CA 125 assay and the ABBOTT CA 125 II™ RIA assay. IMx CA 125 is intended to be used as an aid in monitoring the response to therapy of epithelial ovarian cancer patients while the CA 125 II RIA is intended to be used as an aid in the detection of residual ovarian carcinoma in patients who have undergone first line therapy and would be considered for diagnostic second look procedures. Both assay intended uses reflect a monitoring claim. A linear regression analysis between these two assays, using 493 specimens with IMx CA 125 assay values ranging from 2.0 to 22,821.0 U/mL, yielded a correlation coefficient of 0.997, slope of 0.94, and y-intercept of -4.7 U/mL. The dynamic range of IMx CA 125 is 0 - 600 U/mL with a sensitivity of 2 U/mL. The dynamic range of CA 125 II RIA is 0 - 500 U/mL with a sensitivity of 0.4 U/mL. Receiver Operating Characteristic (ROC) analyses on specimen values from 130 apparently healthy females plus 45 patients with benign gynecologic conditions vs. 197 patients with ovarian cancer gave substantially equivalent areas under the curve of 0.87 for IMx CA 125 and 0.80 for CA 125 II RIA. Using 35 U/mL as the reference value, similar sensitivities of 64.0 and 66.0% and specificities of 96.0 and 92.0% were obtained for IMx CA 125 and CA 125 II RIA, respectively. The concordance at 35 U/mL was 96.2%, 95.6%, 97.0%, and 94.1% for 130 apparently healthy females, 45 patients with benign gynecologic conditions, 197 patients with ovarian cancer, and 542 total subjects, respectively. Serial tracking data on 55 patients with ovarian cancer showed comparable trending results for both assays. Serial IMx CA 125 results showed good agreement with the clinical status of 39 of the ovarian cancer patients evaluated. In conclusion, these data demonstrate that the Abbott IMx CA 125 assay is as safe and effective as, and is substantially equivalent to the ABBOTT CA 125 II RIA assay. Prepared and Submitted October 18, 1996 (edited September 18, 1997) by: Joy C. Sonsalla 200 Abbott Park Road Abbott Laboratories Abbott Park, IL 60064 Page 45 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV - 4 1997 Ms. Joy C. Sonsalla Senior Regulatory Specialist Abbott Laboratories Diagnostic Division ADD Regulatory Affairs Department D9V6, Building AP31 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K964185/S3 Trade Name: ABBOTT IMx® CA 125™ Regulatory Class: II Tier III Product Code: LTK Dated: September 18, 1997 Received: September 19, 1997 Dear Ms. Sonsalla: 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 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 requirement, 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. {2} 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, 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 {3} OCT 29 '97 03:38PM ADD REGULATORY AFFAIRS: DEVICES P.2/3 510(k) Number (if known): K964185 Device Name: IMx® CA 125™ Indications for Use: The IMx® CA 125™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 125 assay values in human serum. The IMx® CA 125™ assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. ![img-0.jpeg](img-0.jpeg) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Perscription Use ☑ (Per 21CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK/K964185](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK/K964185) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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