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 Thyroid 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 Peroxidase 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 a breakdown of the acceptance criteria and study details based on the provided text, focusing on the UniCAP® Thyroglobulin IgG Assay and UniCAP® Thyroid Peroxidase IgG Assay:

The submission describes a comparison study performed to demonstrate substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance characteristics against a clinical ground truth. Therefore, the "acceptance criteria" are implicitly met by demonstrating strong correlation with the predicate device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (UniCAP® Thyroglobulin IgG Assay)	Reported Device Performance (UniCAP® Thyroid Peroxidase IgG Assay)
Substantial equivalence to predicate device (Varelisa® TG Antibody Assay)	Linear regression: Y = 1.04 * X + 11 (correlation coefficient 0.99)	Linear regression: Y = 1.04 * X (correlation coefficient 0.99)

Study Details

Sample size used for the test set and data provenance:
- Sample Size: 100 serum samples for UniCAP® Thyroglobulin IgG Assay and 100 serum samples for UniCAP® Thyroid Peroxidase IgG Assay.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only states "100 serum samples were collected".
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth was established by comparing the device's results to a legally marketed predicate device (Varelisa® TG Antibody Assay and Varelisa® TPO Antibody Assay) rather than expert consensus on patient conditions.
Adjudication method for the test set:
- Not applicable. The study involved a direct comparison of quantitative measurements from two different assay systems.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an in vitro diagnostic device for quantitative measurement of antibodies, not an imaging or diagnostic aid for human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The UniCAP® assays were run independently, and their results were compared to the results from the predicate Varelisa® assays.
The type of ground truth used:
- Reference device/predicate device performance: The "ground truth" for this substantial equivalence study was the results obtained from the legally marketed predicate devices: Varelisa® Thyroglobulin Antibodies Assay and Varelisa® Thyroid Peroxidase Antibodies Assay.
The sample size for the training set:
- Not applicable. This is a medical device submission for an in vitro diagnostic assay, not a machine learning or AI-based device that typically involves training sets. The assessment is based on direct performance comparison.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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7 1998 JULL

UniCAP® Thyroglobulin IgG Assay / UniCAP® Thyroid Peroxidase IgG Assay K981559 V 510(k) Submission Section 11. Summary of Safety and Effectiveness

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® Thyroglubulin IgG AssayUniCAP® Thyroid Peroxidase IgG AssayUniCAP® Thyroglobulin IgG Antibodies Control NLHUniCAP® Thyroid Peroxidase IgG Antibodies ControlNLH
Common Name:	Thyroid autoantibody immunological test system.

510k/utgtp11

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UniCAP® Thyroglobulin IgG Assay / UniCAP® Thyroid Peroxidase IgG Assay 510(k) Submission Section 11. Summary of Safety and Effectiveness

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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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.

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 seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three heads, symbolizing health, hope, and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.

7 1998 JUL

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

Re: K981559 Trade Name: UniCAP® Thyroglobulin IgG Assay Regulatory Class: II Product Code: JZO Dated: April 30, 1998 May 1, 1998 Received:

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 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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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 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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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 witro 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 requlation 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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UniCAP® Thyroglobulin IgG Assay/ UniCAP® Thyroid Peroxidase IgG Assay 510(k) Submission Section 1. Intended Use Statements

K981559

510(k) Number (if known):

Device Name: UniCAP® Thyroglobulin IgG Assay

Indications For Use: UniCAP Thyrodlobulin 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 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 conjunction with other clinical findings, and is to be used in clinical laboratories, as well/as physician office laboratories.

Titic. Maker

(Division Sign-Off) Division of Clinical Laboratory De 610(k) Number

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

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UniCAP® Thyroglobulin IgG Assay/ UniCAP® Thyroid Peroxidase IgG Assay 510(k) Submission Section 1. Intended Use Statements

510(k) Number (if known):

Device Name: UniCAP® Thyroglobulin IgG Antibodies Control NLH

K981559

Indications For Use: 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

Over-The-Counter Use

(Per 21 CFR 801.109)

00003 00

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).