ImmunoCAP Thyrodlobulin is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP Thyroglobulin is intended to be used with the ImmunoCAP 100° and ImmunoCAP 250 instruments. 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 physicians office laboratories.

ImmunoCAP Thyroid Peroxidase is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. ImmunoCAP Thyroid Peroxidase is intended to be used with the ImmunoCAP 100C and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, Graves' disease and is to be used in clinical laboratories, as well as physicians office laboratories.

ImmunoCAP Thyroglobulin IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroglobulin antibodies in human serum. ImmunoCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100° and ImmunoCAP 250.

ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroid Peroxidase antibodies in human serum. ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100€ and ImmunoCAP 250.

Device Description

The modified devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using ImmunoCAP single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the ImmunoCAP IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

AI/ML Overview

The provided document is a 510(k) Summary for the ImmunoCAP™ Thyroglobulin and ImmunoCAP™ Thyroid Peroxidase immunological test systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria and proving performance against them from scratch. Therefore, many of the requested details about a study proving the device meets acceptance criteria are not explicitly stated in the document in the format one might expect for a de novo device submission.

However, based on the information provided, here's an attempt to answer the questions, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantified acceptance criteria or reported device performance in a table format. Instead, it relies on demonstrating laboratory equivalence to previously cleared predicate devices (UniCAP TG Antibodies K981559 and UniCAP TPO Antibodies K981930). The "acceptance criteria" can be inferred as successful comparability and substantial equivalence to these predicates.

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence to Predicate Devices (UniCAP TG Antibodies K981559, UniCAP TPO Antibodies K981930)	"all available data support that the modified devices are substantially equivalent to the previously cleared devices." This is based on: Comparison studies between modified and previously cleared devices.Results obtained for clinically defined sera.Results obtained for samples from apparently healthy subjects (normal population).
Reduction of interference from cellulose IgG antibodies	Device modification includes "the addition of a blocking diluent to reduce interference from cellulose IgG antibodies" (implied successful).
Compatibility with ImmunoCAP 100 and ImmunoCAP 250 instruments	The device is intended to be used with these instruments.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the comparison studies or the provenance of the data (e.g., country of origin, retrospective/prospective). It mentions:

"results obtained for clinically defined sera"
"results obtained for samples from apparently healthy subjects (normal population)"

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The ground truth for "clinically defined sera" and "apparently healthy subjects" is typically established through clinical diagnosis and standard laboratory tests, but the involvement of specific experts or their qualifications is not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not relevant to this type of in vitro diagnostic device, which is an automated immunoassay system measuring specific IgG antibodies. This is not an AI-assisted diagnostic tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a standalone in vitro diagnostic system. The "algorithm" here refers to the immunoassay's reaction and instrument's software for evaluation. The document implicitly supports its standalone performance because the "instruments ImmunoCAP 100° and ImmunoCAP 250... include software for evaluation of test results." The equivalence studies described are effectively standalone performance assessments against predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document refers to "clinically defined sera" and "samples from apparently healthy subjects." This suggests the ground truth was based on clinical diagnoses (which could involve a combination of expert assessment, other laboratory tests, and potentially patient outcomes) rather than a single source like pathology for tissue samples.

8. The sample size for the training set

This information is not provided. As this is a modification of an existing device and focuses on demonstrating equivalence, detailed training set information is less likely to be presented than for a de novo AI/ML device. The "training" in this context would typically refer to the development and optimization of the immunoassay itself, not a machine learning model.

9. How the ground truth for the training set was established

This information is not explicitly provided. Similar to the test set, the ground truth for developing and optimizing the assay (if considered a "training set") would likely involve clinically characterized samples, but the method of establishment is not detailed.

Summary

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510(k) Summary of Safety and Effectiveness 8.

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.

Assigned 510(k) Number: 长072661 Date of Summary Preparation: September 20, 2007 Phadia AB Manufacturer: NOV 2 0 2007 Rapsgatan 7 SE-751 37 Uppsala, Sweden Martin Mann 510 (k) Contact Person: Requlatory Affairs Manager Phadia US Inc. 4169 Commercial Avenue Portage, Mi 49002, USA +1 (-269-492) -1957 (Phone) +1 (-269-492) -7541 (Fax) martin.mann@phadia.com ImmunoCAP™ Thyroglobulin ImmunoCAP Device Name: ImmunoCAP™ Thyroid Peroxidase ImmunoCAP ImmunoCAP™ Thyroglobulin IgG Antibodies Controls NLH ImmunoCAP™ Thyroid Peroxidase IgG Antibodies Controls NLH Thyroid Autoantibodies immunological test Common Name:

Classification

Product Name	Product Code	CFR
ImmunoCAP™ ThyroglobulinImmunoCAP™ Thyroglobulin IgGAntibodies Controls NLH	JNL	866.5870
	JNL	866.5870
ImmunoCAP™ Thyroid Peroxidase JZOImmunoCAP™ Thyroid PeroxidaseIgG Antibodies Controls NLH		866.5870
	JZO	866.5870

system

Substantial Equivalence to

UniCAP TG Antibodies UniCAP TPO Antibodies 510(k) number: K981559 510(k) number: K981930

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Intended Use Statements of the Modified Devices

Special condition for use statement

The device is for prescription use only.

Special instrument requirements

ImmunoCAP 100 / ImmunoCAP 250 are fully automated immunoassay analyzers, which include software for evaluation of test results.

General Description of the Modified Devices

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Test Principle of the Modified Devices

The antigen of interest, covalently coupled to immunoCAP, reacts with the specific IgG antibodies in the diluted patient serum specimen. After washing away non-specific igG, enzyme labeled antibodies against IgG are added to form a complex. After incubation, unbound enzyme-anti-IgG is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgG is present in the specimen. To evaluate the test results, the response for the patient samples are transformed to concentrations with the use of a calibration curve.

Device Modification Description

The modified is a non-competitive solid phase EIA. The device modifications are minor and consist of brand name changes, (UniCAP to ImmunoCAP), the addition of a blocking diluent to reduce interference from cellulose IgG antibodies, and packaging configurations. The ImmunoCAP 250 instrument has also been added to the Directions for Use, as part of the ImmunoCAP family of instruments. ImmunoCAP Thyrogiobulin and ImmunoCAP Thyroid Peroxidase are used as an aid in the diagnosis of thyroid diseases, such as autoimmune thyroiditis and Graves' Disease, in conjunction with other laboratory and clinical findings.

Laboratory equivalence

The comparability of the previously cleared devices and the modified devices is supported by data including

· results obtained within a comparison studies between modified and previously cleared devices
· results obtained for clinically defined sera
· results obtained for samples from apparently healthy subjects (normal population).

In summary, all available data support that the modified devices are substantially equivalent to the previously cleared devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a caduceus, which is a symbol of medicine. The caduceus is made up of three wavy lines, and it is surrounded by a circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 0 2007

Phadia US Inc. c/o Mr. Martin R. Mann Regulatory Affairs Manager 4169 Commercial Ave Portage, MI 49002

Re: K072661

Trade/Device Name: ImmunoCAP Thyroglobulin

ImmunoCAP Thyroid Peroxidase ImmunoCAP Thyroglobulin IgG Antibodies Controls NLH ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls NLH Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibodies immunological system Regulatory Class: Class II Product Code: JNL, JZO, JJY Dated: October 30, 2007 Received: October 31, 2007

Dear Mr. Mann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 -

forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Josephine Bautista
Robert L. Becker, Jr., M.D., Ph.D.
Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

K022661

Device Name:

ImmunoCAP™ Thyroglobulin ImmunoCAP

Indications For Use:

ImmunoCAP Thyroglobulin is a device for the in vitro quantitative measurement of IgG intibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP and outer specific for Thyrogiousin (10) in haman coal 100c and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of instruments. It is intendou rich as autoimmune thyroiditis and Graves' disease, and is to be used in clinical laboratories, as well as physician's office laboratories.

Maria m chon
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

313(k) K072661

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Indications for Use

510(k) Number:

K072661

Device Name:

ImmunoCAPTM Thyroid Peroxidase ImmunoCAP

Indications For Use:

ImmunoCAP Thyroid Peroxidase is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. ImmunoCAP Thyroid Peroxidase is intended to be used with the ImmunoCAP 100° and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, Graves' disease and is to be used in clinical laboratories, as well as physician's office laboratories.

Mana M. Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072661

V AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Indications for Use

510(k) Number:

K072661

Device Name:

ImmunoCAP™ Thyroglobulin IgG Antibodies Controls NLH

Indications For Use:

Mana m Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072661

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CONFIDENTIAL AND PROPRIETARY

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Indications for Use

510(k) Number:

KD72661

Device Name:

ImmunoCAPTM Thyroid Peroxidase IgG Antibodies Controls NLH

Indications For Use:

M. Chan

Division Sign-Off

Office of In Vito Diagnostic Device Evaluation and Safety

K072661

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).