(42 days)
IMMULITE® 2000 Anti-TPO Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of antithyroid peroxidase in serum and EDTA plasma, as an aid in the clinical diagnosis of thyroid diseases.
IMMULITE® 2000 Anti-TPO Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer
This document describes the IMMULITE® 2000 Anti-TPO Ab device, an in vitro diagnostic assay for the quantitative measurement of antithyroid peroxidase in serum and EDTA plasma, used as an aid in the clinical diagnosis of thyroid diseases. The provided text is a 510(k) summary for regulatory clearance and focuses on substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data in the format requested.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a specific table of acceptance criteria or quantified performance metrics from a study to prove the device meets those criteria. The clearance is based on substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided document. The 510(k) summary focuses on the device itself and its intended use, not on specific clinical study data details like test sets or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not available in the provided document.
4. Adjudication Method for the Test Set:
This information is not available in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned in the provided document. This type of study is more common for imaging devices or diagnostic tools where human interpretation is a key component. The IMMULITE® 2000 Anti-TPO Ab is an automated immunoassay.
6. If a Standalone Study Was Done:
The document states that 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-TPO Ab." This implies that data was presented to demonstrate the device's performance, likely in comparison to the predicate device, but the details of this "standalone" performance study (if it can be called that in the context of the requested information) are not detailed. It is highly probable that performance claims (e.g., precision, accuracy, linearity) would have been substantiated by internal studies, but these are not explicitly described nor are their results presented in this summary.
7. The Type of Ground Truth Used:
This information is not explicitly stated in the provided document. For an immunoassay, the "ground truth" would typically be established by comparison to a reference method, a well-characterized set of patient samples with known clinical diagnoses, or results from the predicate device that has established clinical utility.
8. The Sample Size for the Training Set:
This information is not available in the provided document. As this is an immunoassay (a laboratory test) rather than an AI/ML-based diagnostic device, the concept of a "training set" for an algorithm is generally not applicable in the same way as described in the prompt.
9. How the Ground Truth for the Training Set Was Established:
This information is not available in the provided document, as the concept of a "training set" for an algorithm is generally not directly applicable to this type of immunoassay.
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MAY 1 3 1999
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
1991096
(310) 645-8200 (310) 645-9999
Edward M. Levine, Ph.D. Director of Clinical Affairs
March 31, 1999
L2KTO2 (200 tests), L2KTO6 (600 tests)
IMMULITE® 2000 Anti-TPO Ab
Reagent system for the measurement of antithyroid peroxidase in serum and EDTA 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-TPO Ab (K963695)
IMMULITE® 2000 Anti-TPO 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-TPO Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of antithyroid peroxidase in serum and EDTA 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-TPO Ab.
Edward M. Levine, Ph.D.
Edward M. Levine, Ph.D. Director of Clinical Affairs
3/31/99
Date
Date
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centrally aligned. The words are capitalized, and the overall appearance is clean and professional.
MAY 1 3 1999
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation
5700 West 96th Street Los Angeles, California 90045-5597
K991096 Re: Trade Name: IMMULITE® 2000 Anti-TPO 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 vours.
Steven Butman
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): K991096 Device Name: IMMULITE® 2000 Anti-TPO Ab
Indications For Use:
IMMULITE 2000 Anti-TPO Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer for the quantitative measurement of antithyroid peroxidase (TPO) antibodies in serum and EDTA 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)
Tuta E. Maker
(Division Sign-Off)
Division of Clinical Laboratory De-510(k) Number
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).