← Product Code [JZO](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZO) · K991096 # IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 (K991096) _Diagnostic Products Corp. · JZO · May 13, 1999 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZO/K991096 ## Device Facts - **Applicant:** Diagnostic Products Corp. - **Product Code:** [JZO](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZO.md) - **Decision Date:** May 13, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.5870 - **Device Class:** Class 2 - **Review Panel:** Immunology ## 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 in serum and EDTA plasma, as an aid in the clinical diagnosis of thyroid diseases. ## Device Story IMMULITE 2000 Anti-TPO Ab is an in vitro diagnostic reagent system used with the IMMULITE 2000 Automated Immunoassay Analyzer. The device measures antithyroid peroxidase antibodies in patient serum or EDTA plasma samples. The analyzer performs the assay, providing quantitative results to clinicians. Used in clinical laboratory settings to assist in the diagnosis of thyroid diseases. The output allows healthcare providers to assess thyroid function and autoimmune status, aiding in clinical decision-making and patient management. ## Clinical Evidence No clinical data provided in the summary; substantial equivalence is based on performance characteristics and technological similarities to the predicate device. ## Technological Characteristics In vitro diagnostic reagent system for use on the IMMULITE 2000 Automated Immunoassay Analyzer. Utilizes automated immunoassay technology for quantitative measurement of antithyroid peroxidase antibodies. Form factor consists of reagent kits (200 or 600 tests). ## Regulatory 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. ## Predicate Devices - IMMULITE® Anti-TPO Ab ([K963695](/device/K963695.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 | mm {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ Page 2 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 {4}------------------------------------------------ ## 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) --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZO/K991096](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZO/K991096) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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