(379 days)
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 125M 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.
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.
Here's a breakdown of the acceptance criteria and study details for the IMx® CA 125™ device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in this document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (ABBOTT CA 125 II™ RIA assay) across several performance metrics. Therefore, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" shows how the new device compares.
| Performance Metric | Predicate Device (ABBOTT CA 125 II RIA) Performance (Implied Acceptance Criteria) | IMx® CA 125™ Reported Performance |
|---|---|---|
| Correlation Coefficient (vs. predicate) | Close to 1.0 (ideally >= 0.95 or specific range) | 0.997 |
| Slope (vs. predicate) | Close to 1.0 (ideally between 0.9 and 1.1) | 0.94 |
| Y-intercept (U/mL) (vs. predicate) | Close to 0 (ideally within a small acceptable range) | -4.7 U/mL |
| Dynamic Range | 0 - 500 U/mL | 0 - 600 U/mL |
| Sensitivity | 0.4 U/mL | 2 U/mL |
| Area Under the Curve (ROC analysis) | 0.80 | 0.87 |
| Sensitivity (at 35 U/mL) | 66.0% | 64.0% |
| Specificity (at 35 U/mL) | 92.0% | 96.0% |
| Concordance (at 35 U/mL, Healthy Females) | Implicitly high for predicate | 96.2% |
| Concordance (at 35 U/mL, Benign Gyn Conditions) | Implicitly high for predicate | 95.6% |
| Concordance (at 35 U/mL, Ovarian Cancer) | Implicitly high for predicate | 97.0% |
| Concordance (at 35 U/mL, Total Subjects) | Implicitly high for predicate | 94.1% |
| Serial Tracking Agreement (Ovarian Cancer Patients) | Implicitly good agreement with clinical status | Good agreement for 39 out of 55 patients evaluated (IMx results with clinical status) |
2. Sample Size Used for the Test Set and Data Provenance
- Linear Regression Analysis: 493 specimens
- Receiver Operating Characteristic (ROC) Analysis: 130 apparently healthy females + 45 patients with benign gynecologic conditions (control groups) + 197 patients with ovarian cancer (disease group). Total: 372 specimens.
- Concordance Analysis: 130 apparently healthy females, 45 patients with benign gynecologic conditions, 197 patients with ovarian cancer, and 542 total subjects (overlaps with ROC and includes other samples not detailed).
- Serial Tracking Data: 55 patients with ovarian cancer.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) submission in the US, it's highly likely to be U.S.-based clinical samples. It is not explicitly stated whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" being used to establish ground truth for the test set in the same way one might assess imaging data. The ground truth for this diagnostic device is based on established clinical diagnoses (e.g., "apparently healthy females," "patients with benign gynecologic conditions," "patients with ovarian cancer," "clinical status of ovarian cancer patients"). Therefore, experts in establishing ground truth (like radiologists for imaging) are not directly applicable in the terms usually used for device performance. The clinical status of the serial tracking patients would have been determined by treating physicians based on standard clinical practices, but the number and qualifications of these individuals are not specified.
4. Adjudication Method for the Test Set
Not applicable. The ground truth is based on clinical diagnosis or classification of patient groups, not subjective interpretation requiring adjudication of individual results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a blood-based immunoassay, not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies reported are standalone performance of the IMx® CA 125™ assay. It directly measures the CA 125 assay values in human serum and compares these quantitative results to those of the predicate device and relevant clinical categories. There is no explicit human-in-the-loop component discussed for the performance evaluation itself, although the results are intended to aid clinicians.
7. The Type of Ground Truth Used
The ground truth used is primarily clinical diagnosis/classification and clinical status (for monitoring).
- For ROC analysis, ground truth was "apparently healthy," "benign gynecologic conditions," and "ovarian cancer."
- For serial tracking, ground truth was the "clinical status" of ovarian cancer patients.
- For comparisons with the predicate, the predicate device's results serve as a reference point for correlation, slope, and intercept analysis.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. This immunoassay is a chemical detection system, not an AI/ML algorithm that requires training. The 493 specimens used for linear regression and the 372 specimens for ROC analysis are essentially the test set used to demonstrate performance for substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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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 UlmL with a sensitivity of 0.4 UlmL. 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 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES ---
Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or abstract shape, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Joy C. Sonsalla Senior Requlatory Specialist Abbott Laboratories Diagnostic Division ADD Regulatory Affairs Department D9V6, Building AP31 200 Abbott Park Road Abbott Park, Illinois 60064-3537
NOV - 4 1997
Re : K964185/S3 ABBOTT IMx® CA 125™ Trade Name: Regulatory Class: II Tier III Product Code: LTK September 18, 1997 Dated: 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, labelinq, 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 Reqister. 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 Requlations.
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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 Autman
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
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510(k) Number (if known): K964185
Device Name: IMx® CA 125TM
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 125M 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.
Peter E. Mafim
(Division Sign-Off, Division of Clinical Laboratory Devi 510(k) Numb
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of DeviceEvaluation (ODE)
Perscription Use V (Per 21CFR 801.109)
서는 그 바꾸구 부르 한 바이크 바 아르 바 아버 아버 아이브 바 아이폰 마스크 노르드 바 역
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
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.(b)
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.