(56 days)
The Thyroglobulin ELISA Assay is intended for the quantitative determination of thyroglobulin (TG) in human serum or plasma in patients who do not have TG antibodies; to aid in confirming the diagnosis of thyroid diseases, such as Graves' Disease; and to monitor for the absence of thyroglobulin in thyroidectomized patients.
Not Found
Thislooks like a 510(k) clearance letter for an ELISA assay, not a study evaluating an AI/ML device. Therefore, the questions regarding acceptance criteria, study design, and performance metrics for an AI/ML device are not applicable to the provided document.
The document discusses the regulatory clearance of the "ALPCO Thyroglobulin ELISA Assay" based on its substantial equivalence to a predicate device, as per the FDA's 510(k) process. It outlines the intended use of the assay for quantitative determination of thyroglobulin in human serum or plasma to aid in diagnosing thyroid diseases and monitoring thyroidectomized patients.
Here's why the questions are not applicable:
- Acceptance Criteria for AI/ML and Reported Device Performance: This document does not describe performance metrics like sensitivity, specificity, AUC, etc., that would be relevant for an AI/ML device study. It's about a laboratory assay.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth Type, Training Set Size, Training Set Ground Truth: All these questions pertain to the design and results of a clinical study or validation for an AI/ML system, which is not what this document represents.
In summary, the provided text is a regulatory clearance letter for an in-vitro diagnostic (ELISA) assay, not a study report or clinical trial documentation for an AI/ML-driven medical device. Therefore, none of the requested information can be extracted.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Anministration 2098 Gaither Road Rockville MD 20850
Mr. Richard Conley President American Laboratory Products Company P.O. Box 451 . - ... Windham, New Hampshire 03087
JUL 1 4 1997
Re: K972190 ALPCO Thyroglobulin ELISA Assay Trade Name: Product Code: JZO Requlatory Class: II MSM II May 14, 1997 Dated: Received: May 19, 1997
Dear Mr. Conley:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 Requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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) Additionally, for questions on the promotion and 594-4588. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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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510(k) Number (if known):
ALPCO/ORGenTec Thyroglobulin Assay Device Name:
Indications For Use:
The Thyroglobulin ELISA Assay is intended for the quantitative determination of thyroglobulin (TG) in human serum or plasma in patients who do not have TG antibodies; to aid in confirming the diagnosis of thyroid diseases, such as Graves' Disease; and to monitor for the absence of thyroglobulin in thyroidectomized patients.
FDA DCLD
Peter E. Madine
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Page,
of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) :
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
6003
§ 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).