(163 days)
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No
The summary describes an in vitro diagnostic assay for measuring antibodies, with no mention of AI or ML technologies.
No
This product is an in vitro diagnostic device used for measurement and diagnosis, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "AIA-PACK TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY" and that its measurements "aid in the diagnosis of autoimmune thyroid disorders."
No
The device is an in vitro diagnostic (IVD) assay kit intended for use on specific hardware analyzers (TOSOH AIA System analyzers). It measures a biological marker (TPOAb) in a biological sample (human serum), which is characteristic of a traditional IVD kit, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"AIA-PACK TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroid peroxidase antibodies (TPOAb) in human serum on specific TOSOH AIA System analyzers."
This statement clearly indicates that the device is designed to be used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
AIA-PACK TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroid peroxidase antibodies (TPOAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves' disease and Hashimoto's disease.
Product codes
JZO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
OCT 8
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lori Robinson Manager, Quality Assurance TOSOH Medics, Inc. 373 D Vintage Park Drive Foster City, California 94404
Re: K981521/S1
Trade Name: AIA-PACK TPOAb Assay Requlatory Class: II Product Code: JZO Dated: June 26, 1998 Received: July 14, 1998
Dear Ms. Robinson:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory 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.
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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 vitro 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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Image /page/2/Picture/0 description: The image shows the logo for TOSOH MEDICS, INC. The logo consists of a stylized four-leaf clover shape with a square in the center, along with the text "TOSOH MEDICS, INC." The word "TOSOH" is also written in a smaller font below the clover shape. The logo is simple and professional, and it is likely used to represent the company's brand.
K98152
PREMARKET NOTIFICATION
INDICATION FOR USE STATEMENT
AIA-PACK TPOAb Assay
AIA-PACK TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroid peroxidase antibodies (TPOAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves' disease and Hashimoto's disease.
Peter E. Macfmi.
Division Sic 510(k) Number