UniCAP Thyroglobulin ImmunoCAP™ is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. UniCAP Thyroglobulin ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Thyroid Peroxidase ImmunoCAP is a device for the in vitro quantitative measurement of IgG antibodies specific for Thvroid Peroxidase (TPO) in human serum and plasma. UniCAP Thyroid Peroxidase ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Specific IgG is an in vitro test system for the quantitative and qualitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component of the UniCAP Specific IgG System. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

UniCAP Thyroglobulin IgG Antibodies Controls are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin in human serum. UniCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument UniCAP.

UniCAP Thyroid Peroxidase IgG Antibodies Controls are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxicase in human serum. UniCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument UniCAP.

Device Description

UniCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. UniCAP System is comprised of Instruments (UniCAP 100 Analyzer, Test System Modules and Assay Products (Fluororenzymeimmunoassays for the measurement of IgE, IgG). ImmunoCAP™ Antigens (solid phase components which contain the specific antigens to be measured), and Software Accessories.

UniCAP 100 Analyzer is designed to handle all steps from sample and reagents handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software.

UniCAP® 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer or network server.

UniCAP Specific IgG is a fluoroenzymeimmunoassay for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component. Specific IgG antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Thyroglobulin and Thyroid Peroxidase, which are covalently coupled to ImmunoCAP.

The UniCAP Thyroid Peroxidase ImmunoCAP contains recombinant human Thyroid Peroxidase covalently coupled to a cellulose matrix. The UniCAP Thyroglobulin ImmunoCAP contains purified human Thyroglobulin covalently coupled to the cellulose matrix.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in terms of numerical thresholds for correlation coefficients or regression equations. Instead, the acceptance criterion for both UniCAP Thyroglobulin IgG Assay and UniCAP Thyroid Peroxidase IgG Assay is implicitly defined as "substantially equivalent" to their respective legally marketed predicate devices (Varelisa® Thyroglobulin Antibodies Assay and Varelisa® Thyroid Peroxidase Antibodies Assay). This substantial equivalence is demonstrated through a comparison study and statistical analysis.

Acceptance Criteria (Implicit)	Reported Device Performance (UniCAP Thyroglobulin IgG Assay)	Reported Device Performance (UniCAP Thyroid Peroxidase IgG Assay)
Substantial equivalence to predicate device (Varelisa® Thyroglobulin Antibodies Assay) via correlation.	Linear regression equation: Y = 1.04 * X + 11 Correlation coefficient: 0.99	Not applicable to this assay.
Substantial equivalence to predicate device (Varelisa® Thyroid Peroxidase Antibodies Assay) via correlation.	Not applicable to this assay.	Linear regression equation: Y = 1.04 * X Correlation coefficient: 0.99

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 100 serum samples for UniCAP Thyroglobulin IgG Assay and 100 serum samples for UniCAP Thyroid Peroxidase IgG Assay.
Data Provenance: The document does not specify the country of origin for the serum samples. It is a retrospective study using collected serum samples to compare the new device against the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to this submission. For in vitro diagnostic (IVD) assays like the UniCAP series, the "ground truth" for the test set is established by the measurements obtained from the predicate device (Varelisa® assays in this case), and the study aims to show correlation with those established measurements. There are no human experts "establishing ground truth" in the way one might for an imaging AI device.

4. Adjudication Method for the Test Set

Not applicable. The study design is a direct comparison of quantitative measurements from two different assay systems (new device vs. predicate device) on the same serum samples. There is no human adjudication process involved in comparing the results of the two assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This submission is for an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study and effects on human reader performance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, effectively. The performance described is for the UniCAP assays operating in a "standalone" manner, meaning the device itself measures the antibodies in serum samples and provides a quantitative result. There is no explicit "human-in-the-loop" component for interpretation described in the performance study, beyond the standard operation of an IVD system by laboratory personnel. The device's output (quantitative measurement) is directly compared to the predicate device's output.

7. The Type of Ground Truth Used

The ground truth or reference standard for this study is the measurements obtained from the legally marketed predicate devices:

Varelisa® Thyroglobulin Antibodies Assay for the UniCAP Thyroglobulin IgG Assay.
Varelisa® Thyroid Peroxidase Antibodies Assay for the UniCAP Thyroid Peroxidase IgG Assay.

The study aims to demonstrate that the new devices' results are in close statistical agreement (correlation) with these established methods.

8. The Sample Size for the Training Set

Not explicitly stated/Not applicable in the conventional sense. For IVD assays, "training set" doesn't typically refer to a data set used to train an AI algorithm. Instead, the development and verification process for IVDs involve method validation studies (e.g., linearity, precision, interference) and internal studies using various samples to establish performance characteristics. The submission does not detail the sample sizes used for these internal development and validation phases. The specific "comparison study" sample sizes are for demonstrating substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of machine learning, this question for an IVD assay is not applicable. The "ground truth" for an IVD's development would stem from clinical studies, established reference methods, and clinical relevance to disease states, which are part of the broader development process for any diagnostic test. For the comparison study, the predicate device serves as the reference.

Summary

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JUL 7 1998

UniCAP® Thyroglobulin IgG Assay / UniCAP® Thyroid Peroxidase IgG Assay 510(k) Submission

Section 11. Summary of Safety and Effectiveness

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SUMMARY OF SAFETY AND EFFECTIVENESS 11.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

Date of Summary Preparation:	June 23, 1998
Distributor:	Pharmacia & UpjohnDiagnostics Division, US Operation7425-248-17000 Portage RoadKalamazoo, MI 49001
Manufacturer:	Pharmacia & Upjohn, Diagnostics ABS-751 82 Uppsala, Sweden
Company Contact Person:	Karen E. MatisRegulatory Affairs ManagerDiagnostics DivisionUS Operation7000 Portage Road7425-248-01Kalamazoo, MI 49001(614) 794-3324 (Phone)(614) 794-0266 (Fax)
Device Names:	UniCAP® Thyroglobulin IgG AssayUniCAP® Thyroid Peroxidase IgG AssayUniCAP® Thyroglobulin IgG Antibodies Control NLHUniCAP® Thyroid Peroxidase IgG Antibodies ControlNLH
Common Name:	Thyroid autoantibody immunological test system.

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Classification:

Product Name	Product Code	Class	CFR
UniCAP® Thyroglobulin IgG Assay	82JNL	II	866.5870
UniCAP Thyroid Peroxidase IgGAssay	82JZO	II	866.5870
UniCAP Thyroglobulin IgGAntibodies Control NLH	82JNL	II	866.5870
UniCAP Thyroid Peroxidase IgGAntibodies Control NLH	82JZO	II	866.5870

Substantial Equivalence to:

Varelisa® Thyroglobulin Antibodies Assay Varelisa Thyroid Peroxidase Antibodies Assay

Intended Use Statement ;

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UniCAP® Specific IgG is an in vitro test system for the quantitative and qualitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component of the UniCAP Specific IgG System. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

General Description

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Comparison Data:

UniCAP Thyroglobulin IgG Assay

A comparison study was performend to generate correlation data between UniCAP Thyroglobulin IgG Assay and Varelisa® TG Antibody Assay. This study was performed to demonstrate that the performance of UniCAP Thyroglobulin IgG Assay is substantially equivalent to Varelisa TG Antibody Assay, which is the legally marketed predicate device in the United States. 100 serum samples were collected and were run on both assay systems with the following results.

Linear regression analysis gave the equation:

Y = 1.04 * X + 11 with correlation coefficient 0.99

This correlation study demonstrated that the new device, UniCAP Thyroglobulin IgG Assay is substantially equivalent to the legally marketed predicate device. Varelisa Thyroglobulin Antibodies Assay.

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UniCAP® Thyroid Peroxidase IgG Assay

A comparison study was performed to generate correlation data between UniCAP Thyroid Peroxidase IgG Assay and Varelisa® TPO Antibody Assay. This study was performed to demonstrate that the performance of UniCAP Thyroid Peroxidase IgG Assay is substantially equivalent to Varelisa TPO Antibody Assay, which is the legally marketed predicate device in the United States. 100 serum samples were collected and were run on both assay systems with the following results.

Linear regression analysis gave the following equation:

Y = 1.04 * X with correlation coefficient 0.99

This correlation study demonstrated that the new device. UniCAP Thyroid Peroxidase IgG Assay is substantially equivalent to the legally marketed predicate device, Varelisa Thyroid Peroxidase Antibodies Assay.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, resembling an abstract representation of people.

7 1998 JUL

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen E. Matis Regulatory Affairs Manager Pharmacia & Upjohn Diagnostics Division, US Operations 5094 St. Andrews Drive Westerville, Ohio 43082

Re : K981930 UniCAP® Thyroid Peroxidase IgG Assay Trade Name: Requlatory Class: II Product Code: JZO Dated: April 30, 1998 Received: May 1, 1998

Dear Ms. Matis:

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 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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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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 requlation (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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

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K981930

510(k) Number (if known):

Device Name: UniCAP® Thyroid Peroxidase IgG Assay

Indications For Use: UniCAP Thyroid Peroxidase ImmunoCAP™ is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPQ) in human serum and plasma. UniCAP Thyroid Peroxidase ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aïd in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Specific IgG is an in vitro test system for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgG System. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in coniunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K981930

Prescription Use (Per 21 CFR 801.109)		OR	Over-The-Counter Use
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Regulation Number and Section

§ 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).