(163 days)
No predicate device(s) found.
Not Found
No
The summary describes an in vitro diagnostic assay kit for measuring antibodies, which is a chemical/biological test, not a software-based device utilizing AI/ML. There are no mentions of AI, ML, image processing, or software algorithms.
No
This device is an in vitro diagnostic (IVD) device used for measuring anti-thyroglobulin antibodies to aid in the diagnosis of autoimmune thyroid disorders. It is not used to treat or therapy a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for IN VITRO DIAGNOSTIC USE ONLY" and that "Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders".
No
The device is an in vitro diagnostic assay kit, which is a chemical reagent-based product used with specific hardware analyzers, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "AIA-PACK TgAb is intended for IN VITRO DIAGNOSTIC USE ONLY". This is the primary indicator that the device is an IVD.
Furthermore, the intended use describes measuring a substance (anti-thyroglobulin antibodies) in a human sample (serum) to aid in the diagnosis of diseases (autoimmune thyroid disorders). This aligns perfectly with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AIA-PACK TgAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) 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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
OCT 8 1098
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 : K981522/S1 Trade Name: AIA-PACK TGAb Assay Regulatory 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.
1
Page 2
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 leqally 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 regulation 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 Toutman
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
2
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" below it. To the right of the clover is the text "TOSOH MEDICS, INC." in a bold, sans-serif font. The logo appears to be a company logo for a medical-related business.
PREMARKET NOTIFICATION
INDICATION FOR USE STATEMENT
AIA-PACK TgAb Assay
AIA-PACK TgAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) 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. Malin
(Division Sign-Off) Divisioner Clinical Laboratory Deyic 510(k) Number _
Perception -