(164 days)
The TheraTest EL-Anti-TPO™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroid peroxidase (TPO) in human serum. The TheraTest EL-Anti-TPO™ assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.
The TheraTest EL-Anti-Thyroglobulin™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroglobulin in human serum. The TheraTest EL-Anti-ThyroglobulinTM assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.
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This looks like a 510k clearance letter for a medical device. There is no information in the document to extract an answer for the user's request. There is no mention of acceptance criteria or study details within the given text.
Therefore, I cannot answer the question.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP - 3 2009
TheraTest Laboratories, Inc. c/o Dr. Gabriella Lakos 1111 North Main Street Lombard, IL 60148
Re: K090760
Trade/Device Name: TheraTest EL-Anti-TPO™ and TheraTest EL-Anti-Thyroglobulin™ Regulation Number: 21 CFR 866.5870 Regulation name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: JZO Dated: August 4, 2009 Received: August 7, 2009
Dear Dr. Lakos:
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. Ilsting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Cor
Roma Philip
Maria M. Chan, 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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Indication for Use
510(k) Number (if known): K090760
Device Name: TheraTest EL-Anti-TPOTM TheraTest EL-Anti-Thyroglobulin™
Indication For Use:
The TheraTest EL-Anti-TPO™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroid peroxidase (TPO) in human serum. The TheraTest EL-Anti-TPO™ assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.
The TheraTest EL-Anti-Thyroglobulin™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroglobulin in human serum. The TheraTest EL-Anti-ThyroglobulinTM assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090760
§ 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).