(42 days)
IMMULITE® 2000 Anti-TG Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of autoantibodies to thyroglobulin (TG) in serum, EDTA, and heparinized plasma, as an aid in the clinical diagnosis of thyroid diseases.
IMMULITE® 2000 Anti-TG Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer
The provided text is a 510(k) Summary Safety and Effectiveness for the IMMULITE® 2000 Anti-TG Ab, a reagent system for measuring autoantibodies to thyroglobulin (TG). This document is a regulatory submission for a medical device and thus does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it contain information about AI or machine learning models.
The document states that the Food and Drug Administration (FDA) used the presented data in granting substantial equivalence to the predicate device. However, the actual performance data (e.g., sensitivity, specificity, accuracy) is not included in this summary.
Therefore, I cannot fulfill your request for the tables and other details regarding acceptance criteria, study design, and AI-specific information. The text does not provide this level of detail about the device's performance or the studies that would typically be conducted for such a purpose.
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MAY 1 3 1999
K9G1094
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: Address:
Telephone Number: Facsimile Number:
Contact Person:
Date of Preparation:
Catalog Number:
Device Name Trade:
Common:
Classification:
Manufacturer:
Establishment Registration #:
Substantially Equivalent Predicate Device:
Description of Device:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
(310) 645-8200 (310) 645-9999
Edward M. Levine, Ph.D. Director of Clinical Affairs
March 31, 1999
L2KTG2 (200 tests), L2KTG6 (600 tests)
IMMULITE® 2000 Anti-TG Ab
Reagent system for the measurement of autoantibodies to thyroglobulin (TG) in serum, EDTA, and heparinized plasma
Class II device, 82-JZO (21CFR 866.5870)
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
DPC Registration number is 2017183
IMMULITE® Anti-TG Ab (K980206)
IMMULITE® 2000 Anti-TG Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer
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Intended Use of the Device:
IMMULITE® 2000 Anti-TG Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of autoantibodies to thyroglobulin (TG) in serum, EDTA, and heparinized plasma, as an aid in the clinical diagnosis of thyroid diseases.
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 Anti-TG Ab.
Edwinal Levine
Edward M. Levine, Ph.D. Director of Clinical Affairs
3/31/99
Date
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is black and the background is white. The text is centered in the image.
MAY 1 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Re: K991094 Trade Name: IMMULITE® 2000 Anti-TG Ab Regulatory Class: II Product Code: JZO Dated: March 31, 1999 Received: April 1, 1999
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 Regulations, 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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): Device Name: IMMULITE® 2000 Anti-TG Ab
Indications For Use:
)
IMMULITE 2000 Anti-TG Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer ---INNOLITE 2000 Ani-1 OF16 15 15 15 15 15 15 16 16 16 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 1 heparinized plasma, as an aid in the clinical diagnosis of thyroid diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maxim
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991094
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).