(20 days)
Not Found
No
The summary describes a standard immunoassay kit and analyzer, with no mention of AI or ML in the intended use, device description, or other sections.
No.
The device is an in vitro diagnostic (IVD) assay intended for quantitative measurement of a biomarker and is used as an aid in monitoring response to therapy and detecting residual cancer, not for directly treating a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "It is intended strictly for in vitro diagnostic use".
No
The device description explicitly states it is a "solid-phase, chemiluminescent enzyme immunometric assay" and is intended for use with the "IMMULITE® 2000 Automated Analyzer," indicating it is a physical assay kit and requires hardware (the analyzer) for operation, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "intended strictly for in vitro diagnostic use".
- Device Description: The "Device Description" also refers to it as a "clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer", which is consistent with an IVD.
- Function: The assay measures a specific antigen (CA 125) in a biological sample (serum) to aid in monitoring and detecting cancer, which is a typical function of an IVD.
N/A
Intended Use / Indications for Use
IMMULITE® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use 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.
Product codes
LTK
Device Description
IMMULITE® 2000 OM-MA is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
IMMULITE® OM-MA (K981297)
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.
0
KG8339/
OIT 1 5 1998
510 (k) Summary 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.
| Name: | Diagnostic Products Corporation |
|---|---|
| Address: | 5700 West 96th Street |
| Los Angeles, California 90045-5597 | |
| Telephone Number: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D. |
| Director of Clinical Affairs | |
| Date of Preparation: | September 23, 1998 |
| Catalog Number: | L2KOP2 |
| Device Name | |
| Trade: | IMMULITE® 2000 OM-MA |
| Common: | Reagent system for the measurement of CA 125 |
| antigen in human serum. | |
| Classification: | LTK, class II device |
| Manufacturer: | Euro/DPC Limited |
| Glyn Rhonwy | |
| Lanberis, Gwynedd LL55 4EL | |
| United Kingdom | |
| (Manufactured under a Quality System- | |
| ISO 9001/EN29001/BS 5750) | |
| Sole U. S. Importer: | Diagnostic Products Corporation |
| 5700 West 96th Street | |
| Los Angeles, CA 90045-5597 | |
| Establishment | |
| Registration #: | Euro/DPC - Not applicable |
| DPC Registration number is 2017183 | |
| Substantially Equivalent | |
| Predicate Device: | IMMULITE® OM-MA (K981297) |
| Description of Device: | IMMULITE® 2000 OM-MA is a clinical use device |
| intended for use with the IMMULITE® 2000 | |
| Automated Immunoassay Analyzer | |
| Intended Use of the Device: | IMMULITE® 2000 OM-MA is a solid-phase, |
| chemiluminescent enzyme immunometric assay for | |
| use with the IMMULITE® 2000 Automated | |
| Analyzer and designed for the quantitative | |
| measurement of CA 125 antigen in serum. It is | |
| intended strictly for in vitro diagnostic use 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. |
1
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE 2000 OM-MA
Eliviccl S. Levin
Edward M. Levine, Ph. D Director of Clinical Affairs
9/14/98
Date
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
OCT 1 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director of Clinical Affairs Diaqnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045
Re: K983391 IMMULITE® 2000 OM-MA and IMMULITE® OM-MA Control Trade Name: Module Catalog # L2KOP2 (200 Tests) LOMCM (Control Module) Requlatory Class: II Product Code: LTK Dated: September 23, 1998 September 25, 1998 Received:
Dear Dr. Levine:
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 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 requlatory 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 obliqation 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
Paqe 2
This letter will allow you to beqin 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 address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
510(k) Number (if known):_
Device Name:_IMMULITE® 2000
Indications For Use:
)
IMMULITE® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
Tista E. Madni
(Division Sign-Off)
Division of Clinical Laboratory Devices K98331
510(k) Number
✓
OR
Over-The-Counter Use
(Optional Format 1-2-