(259 days)
Not Applicable
No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device's operation or data analysis.
No.
This device is an in vitro diagnostic (IVD) test for quantitative determination of autoantibodies, intended for use as an aid in diagnosis, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section states: "The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a two-step immunoassay process involving reagents, paramagnetic microparticles, and a chemiluminescent reaction measured by the ARCHITECT i system optics. This involves physical components and chemical reactions, 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 ARCHITECT® Anti-Tg assay is for the "quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma." It also states it is "intended for use as an aid in the diagnosis of thyroid disease." This clearly indicates the device is used to test samples taken from the human body (serum and plasma) to provide information for diagnostic purposes.
- Device Description: The description details a "two-step immunoassay" using "human serum and plasma" samples. This further confirms it's a test performed outside the body on biological samples.
- Predicate Device: The predicate device listed, "Nichols Advantage Thyroglobulin Autoantibodies Assay," is also an IVD, which supports the classification of the ARCHITECT Anti-
N/A
Intended Use / Indications for Use
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease.
The ARCHITECT® Anti-Tg Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
The ARCHITECT® Anti-Tg 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 thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
Product codes
JZO, JJX, JIT
Device Description
The ARCHITECT Anti-Tg assay is a two-step immunoassay for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®
In the first step, sample, assay diluent and Tg coated paramagnetic microparticles are combined and incubated. Anti-Tg present in the sample binds to the Tg coated microparticles. After washing, human IgG acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-Tg in the sample 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-Tg assay is substantially equivalent to the Nichols Advantage Thyroglobulin Autoantibodies assay in terms of precision, linearity, interferences, and stability as demonstrated in nonclinical performance data in this 510(k) submission.
The ARCHITECT Anti-Tg assay demonstrated substantially equivalent to the Nichols Advantage Thyroglobulin Autoantibodies Assay. The sample stability study evaluated ARCHITECT Anti-Ta assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the delectability of Anti-Tg in serum or plasma samples under any of the storage conditions evaluated in this study. A method concordance using the NCCLS Standard (EP-12A) was also conducted with the ARCHITECT Anti-Tg and the Nichols Advantage Thyroglobulin Autoantibodies assays, and as a result. the two systems demonstrated substantial equivalence as indicated by clinical data in this 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Fisher Diagnostics. The logo consists of a circle with the letter 'F' inside it, followed by the words 'Fisher Diagnostics' in bold, sans-serif font. The logo is simple and professional, and it is likely used to identify the company's products and services.
8.3 510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
052308
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:
Device Name: ARCHITECT® Anti-Tg Proprietary/Trade Name: ARCHITECT® Anti-Tg Immunoassay, ARCHITECT® Anti-Tg Calibrators & Controls Common Name: Anti-Tg test system Device Classification: Class II Governing Regulation: 21 CFR 866.5870, 862.1660, 862.1150 FDA Panel: Immunology, Clinical Chemistry Product Code: JZO, JJX, JIT
Identification of Predicate Device:
Nichols Advantage Thyroglobulin Autoantibodies Assay (K983992) Nichols Advantage Chemiluminescence Tri-Level Controls (K972070)
Intended Use of the Device:
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease.
The ARCHITECT® Anti-Tg Calibration of the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
The ARCHITECT® Anti-Tg 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 thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
Description of the Device:
The ARCHITECT Anti-Tg assay is a two-step immunoassay for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®
In the first step, sample, assay diluent and Tg coated paramagnetic microparticles are combined and incubated. Anti-Tg present in the sample binds to the Tg coated microparticles. After washing, anti-
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MAY 10 1006
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ARCHITECT® Anti-Tq Assay Auqust 23, 2005
Image /page/1/Picture/1 description: The image shows the logo for Fisher Diagnostics. The logo consists of a circle with the letter F inside, followed by the words "Fisher Diagnostics" in bold, sans-serif font. The logo is simple and professional, and it is likely used to identify the company's products and services.
human IqG acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-Tg in the sample and the RLUs detected by the ARCHITECT i system optics.
8.4 Comparison of Technological Characteristics:
The ARCHITECT® Anti-Tg and the Nichols Advantage Thyroglobulin Autoantibodies assays use a microparticle immunoassay method for the quantitative determination of Anti-Tg in human serum or plasma. Anti-microbial agent is used as a preservative for all reagent components (microparticles and conjugate) of the Nichols Advantage Thyroglobulin Autoantibodies assay as well as the ARCHITECT Anti-Tg. Both assays have magnetic microparticles as the solid support. The ARCHITECT® Anti-Tg and the Nichols Advantage Thyroglobulin Autoantibodies assays both use acridinium labeled conjugates to generate the chemiluminescent in the assay.
8.5 Summary of Non-Clinical Performance:
The ARCHITECT® Anti-Tg assay is substantially equivalent to the Nichols Advantage Thyroglobulin Autoantibodies assay in terms of precision, linearity, interferences, and stability as demonstrated in nonclinical performance data in this 510(k) submission.
8.6 Summary Clinical Performance
The ARCHITECT Anti-Tg assay demonstrated substantially equivalent to the Nichols Advantage Thyroglobulin Autoantibodies Assay. The sample stability study evaluated ARCHITECT Anti-Ta assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the delectability of Anti-Tg in serum or plasma samples under any of the storage conditions evaluated in this study. A method concordance using the NCCLS Standard (EP-12A) was also conducted with the ARCHITECT Anti-Tg and the Nichols Advantage Thyroglobulin Autoantibodies assays, and as a result. the two systems demonstrated substantial equivalence as indicated by clinical data in this 510(k) submission.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 10 2006
Fisher Diagnostics c/o Ms. M. Heather Cameron Regulatory Compliance Specialist 8365 Valley Pike P.O. Box 307 Middletown, VA 22645
Re: K052308
Trade/Device Name: ARCHITECT® Anti-Tg, ARCHITECT® Anti-Tg Calibrators and ARCHITECT® Anti-Tg Controls Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO, JIT, JJX Dated: August 23, 2005 Received: August 24, 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 (OS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert A. Beckerf
Robert L. Becker, Jr., MD, PhD - 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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APPENDICES
Indications for Use 8.1
Reagent Intended Use 8.1.1
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease.
8.1.2 Calibrators Intended Use
The ARCHITECT® Anti-Tq Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
8.1.3 Controls Intended Use
The ARCHITECT® Anti-Tg 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 thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
510 (k) Number (if known):
Device Name: ARCHITECT® Anti-Tg Immunoassay, ARCHITECT® Anti-Tg Calibrators & Controls
052308
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Mari Cham
Division Sign-Off
Office of In Vitro Diac
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