ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease.

The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serion and plasma.

The ARCHITECT® Anti-TPO Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument), when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human ser im and plasma.

Device Description

The ARCHITECT Anti-TPO assay is a two-step immunoassay for the quantitative determination of anti-TPO in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Cherriflex® In the first step, sample, assay diluent and TPO coated paramagnetic microparticles are combined and incubated. Anti-TPO present in the sample binds to the TPO coated microparticles. After washing, anti-human IGG acridinium labeled conjugate is added in the second step. Following and wash, herearinger and trigger solutions are added to the reaction mixture. The resulting chemiluminessent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-TPO in the samble and the RLUs detected by the ARCHITECT i system optics.

AI/ML Overview

The provided text describes a 510(k) submission for the ARCHITECT® Anti-TPO Immunoassay, which is a medical device for the quantitative determination of anti-TPO antibodies. The document focuses on demonstrating substantial equivalence to a predicate device, the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA).

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for substantial equivalence in this context is method concordance between the new device and the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device (Abbott AxSYM®)	Demonstrated via clinical performance and method concordance (92.6%)
Precision	Demonstrated as substantially equivalent to predicate
Linearity	Demonstrated as substantially equivalent to predicate
Interferences	Demonstrated as substantially equivalent to predicate
Stability	Demonstrated as substantially equivalent to predicate

Study Information

Sample sizes used for the test set and the data provenance:
The document states that a "method concordance using the NCCLS Standard (EP-12A) was also conducted". However, it does not provide the specific sample size used for this clinical performance study or the geographical origin of the data. It is implicitly a retrospective study comparing a new method to an existing one using collected samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For an immunoassay, the "ground truth" often refers to the results obtained from a reference method or a well-established predicate device. The document uses the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) as the predicate for comparison, implying this served as the reference for establishing concordance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication typically applies to studies where human reviewers independently assess data and their discrepancies are resolved. In this case, it's a comparison of automated immunoassay results.
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:
This is not applicable as the device is an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers' interpretation of images or other data.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance presented for the ARCHITECT® Anti-TPO assay is its standalone performance as an automated immunoassay. The comparison is made purely between the results generated by the ARCHITECT® system and the predicate AxSYM® system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA). The new device's results are compared against this established method to demonstrate substantial equivalence.
The sample size for the training set:
This information is not provided and is generally not applicable in the context of a traditional immunoassay device. Immunoassays are based on biochemical reactions and established protocols, not machine learning models that require training sets in the same way.
How the ground truth for the training set was established:
As mentioned above, this is not applicable in the context of this immunoassay device.

Summary

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JUL 1 8 2006

K052407

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5.0 510(K) SUMMARY

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Applicant Name:

M. Heather Cameron Regulatory Compliance Specialist Fisher Diagnostics 8365 Valley Pike P.O. Box 307 Middletown, VA 22645 Phone: 540.869.8163 Fax: 540.869.8129

Establishment Registration Number: 1181121

ldentification of Device:

Proprietary/Trade Name: ARCHITECT® Anti-TPO Immunoassay, ARCHITECT® Anti-TPO Calibrators & Controls Common Name: Anti-TPO test system Device Name: ARCHITECT® Immunoassay, ARCHITECT® Anti-TPO Calibrators & Controls Device Classification: Class II Governing Regulation: 21 CFR 866.5870, 862.1660, 862.1150 FDA Panel: Immunology, Clinical Chemistry Product Code: JZO, JJX, JIT

ldentification of Predicate Device:

Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) (K020348)

Intended Use of the Device:

ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease.

Description of the Device:

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Comparison of Technological Characteristics:

The ARCHITECT® Anti-TPO assay and the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) use a microparticle immunoassay method for the quantitative determination of Anti-TPO in human serum or plasma. Both assays have TPO coated microparticles.

Summary of Non-Clinical Performance:

The ARCHITECT® Anti-TPO assay is substantially equivalent to the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) in terms of precision, linearity, interferences, and stability as demonstrated in non-clinical performance data in this 510(k) submission.

Summary of Clinical Performance:

The ARCHITECT Anti-TPO assay demonstrated substantially equivalent performance to the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Micropaticle Enzyme Immunoassay (MEIA). A method concordance using the NCCLS Standard (EP-12A) was also conducted with the ARCHITECT Anti-TPO assay and Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) and as a result, the two systems demonstrated substantial equivalence as indicated by clinical data in this 510(k) submission (92.6% Concordance).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUL 18 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Fisher Diagnostics c/o Ms. Heather Cameron Regulatory Compliance Specialist 8365 Valley Pike P.O. Box 307 Middletown, VA 22645

Re: K052407

Trade/Device Name: ARCHITECT® Anti-TPO Immunoassay and ARCHITECT® Anti-TPO Calibrators and Controls Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: JZO, JJX, JIT Dated: August 31, 2005 Received: September 2, 2005

Dear Ms. Cameron:

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Robert Albrecht

Robert L. Becker, Jr., MB., 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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ARCHITECT® Anti-TPO Assay August 31, 2005

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4.0 INDICATIONS FOR USE

510 (k) Number (if known): K052407/S

Device Name: ARCHITECT® Anti-TPO Immunoassay, ARCHITECT® Anti-TPO Calibrators & Controls

Indications for use:

Reagent Intended Use:

Calibrators Intended Use:

The ARCHITECT Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.

Controls Intended Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter AND/OR (21 CFR 807 Subpart C)

Use

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Maria Chan

Division Sign-Off

510(k) kos2407

Fisher Diagnostics

Confidential

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).