(320 days)
Not Found
No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device operation or data analysis.
No
The device is an in vitro diagnostic (IVD) assay designed to aid in the diagnosis of autoimmune thyroid disease by measuring anti-TPO levels, not to treat the disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease."
No
The device description clearly outlines a hardware-based immunoassay system (ARCHITECT® i System) that uses reagents, calibrators, and measures chemiluminescent reactions. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma... intended for use as an aid in the diagnosis of autoimmune thyroid disease." This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description details a "Chemiluminescent Microparticle Immunoassay (CMIA)" performed on "human serum and plasma." This further confirms that the testing is done on biological samples outside of the body.
- Calibrators and Controls: The mention of calibrators and controls is typical for IVD assays used to ensure the accuracy and reliability of the test results.
The core function of analyzing biological samples (serum and plasma) to aid in diagnosis is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JZO, JJX, JIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
92.6% Concordance
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUL 1 8 2006
Image /page/0/Picture/3 description: The image shows the logo for Fisher Diagnostics. The logo consists of a stylized letter 'F' enclosed in a circle, followed by the words 'Fisher Diagnostics' in bold, sans-serif font. The logo is simple and professional, and it is likely used to represent the company's brand.
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.
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.
Description of the Device:
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.
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Image /page/1/Picture/1 description: The image shows the logo for Fisher Diagnostics. The logo consists of a stylized letter "F" inside a circle on the left, followed by the text "Fisher Diagnostics" in bold, sans-serif font on the right. The logo is black and white.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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:
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.
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:
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 serum and plasma.
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