(35 days)
No
The document describes a standard immunoassay for measuring a specific antigen in serum using an automated analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the chemical and mechanical aspects of the assay and analyzer.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for measuring antigens in human serum to aid in monitoring cancer treatment, not for directly treating a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
No
The device description clearly states it is a "solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer," indicating it is a hardware-based immunoassay kit used with an analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "For in vitro diagnostic use" and describes its use for measuring an antigen in human serum to aid in monitoring and detecting ovarian cancer. This clearly indicates it's used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description of the immunoassay as a "solid-phase, two-site, chemiluminescent immunometric assay" further supports its nature as a laboratory test performed outside the body.
- Immulite Tumor Marker Controls: The description of the controls also states "It is intended strictly for in vitro use."
The combination of these factors definitively identifies this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Immulite 2500 OM-MA
For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures
Immulite Tumor Marker Controls
TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.
Product codes
LTK, JJY
Device Description
The IMMULITE 2500 OM-MA Immunoassay is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Section 14 - 510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Establishment Names and Registration Numbers:
Siemens Medical Solutions Diagnostics 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 Registration #: 3005250747
NOV -- 5 2007
Siemens Medical Solutions Diagnostics, Ltd. Glyn Rhonwy Llanberis, Caernarfon Gwynedd, LL55 4EL United Kingdom Registration #: 3002806944
Telephone Number: (310) 645-8200 ext. 7524
Facsimile Number: (310) 645-9999
Maya Mahue-Giangreco, Ph.D. Contact Person: Manager, Biostatistics
Date of Preparation: September 27, 2007
Device Trade Name: IMMULITE® 2500 OM-MA Immunoassay
L5KOP Catalog Number:
Device Common Name:
Reagent Reagent system for the measurement of CA 125 antigen in human sera.
Class II device; Product Code: LTK (21 CFR 866.6010) Classification:
A tumor-associated antigen immunological test system is a device that consists 21 CFR 866.6010: of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body This device is intended as an aid in monitoring patients for disease fluids. progress or response to therapy or for the detection of recurrent or residual disease.
Panel: Immunology
We believe the category to be moderate based on previous CLIA Complexity classification of analogous tests. Category:
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- Siemens Medical Solutions Diagnostics Manufacturer: 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900
Siemens Medical Solutions Diagnostics, Ltd. Glyn Rhonwy Llanberis, Caernarfon Gwynedd, LL55 4EL United Kingdom
Substantially Equivalent Predicate Device: IMMULITE 2000 OM-MA Immunoassay (K983391)
Description of Device:
The IMMULITE 2500 OM-MA Immunoassay is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
The IMMULITE 2500 OM-MA is intended for in vitro diagnostic use with the IMMULITE 2500 analyzer - for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.
- The information presented in this Special 510(k) is that which the Food and Conclusion: Drug Administration used in granting Siemens Medical Solutions Diagnostics substantial equivalence for the IMMULITE 2500 OM-MA Immunoassay when compared with the IMMULITE 2000 OM-MA Immunoassay.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 5 2007
Siemens Medical Solutions Diagnostics c/o Maya Mahue-Giangreco, Ph.D. Manager, Biostatistics 5210 Pacific Concourse Drive Los Angeles, CA 90045
Re: K072794
Trade/Device Name: Immulite 2500 OM-MA and Tumor Marker Controls (TMC) Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: LTK, JJY Dated: September 27, 2007 Received: October 1, 2007
Dear Dr. Mahue-Giangreco:
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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert A. Beckerf
Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072794
Device Name: Immulite 2500 OM-MA and Immulite Tumor Marker Controls
Indications For Use:
Immulite 2500 OM-MA
For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures
Immulite Tumor Marker Controls
TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mena M chan
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072794