(78 days)
The BioCheck TSH ElA is intended for the quantitative determination of thyrotropin, or thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
Not Found
The provided text is an FDA 510(k) clearance letter for the BioCheck TSH EIA test kit. It acknowledges the device's substantial equivalence to a predicate device and permits its marketing.
Unfortunately, the document does not contain the detailed study information required to answer the questions about acceptance criteria and device performance.
The letter primarily focuses on regulatory approval, referencing an "Indications for Use Statement" and general compliance with FDA regulations. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
- Sample size or ground truth establishment for a training set.
To obtain this information, one would typically need to consult the full 510(k) submission (which is often publicly available through FDA databases but not provided in this excerpt) or the device's official documentation (e.g., package insert, manual).
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JUN 2 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Biocheck, Inc. c/o Ms. Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, California 91325
Re: K991146
Trade Name: Biocheck Thyroid Stimulating Hormone (TSH) Enzyme Immunoassay Test Kit
Regulatory Class: II Product Code: JLW Dated: May 12, 1999 Received: May 13, 1999
Dear Ms. Hellen:
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 Regulations, 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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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) 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/cdrlvdsma/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
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Indications For Use Statement 1.
Re-state "Indications for Use" to clarify indications of the assay.
The Indications for Use statement was modified to add the intended use of the assay. The statement as found on the required form is as follows. The form is also presented in Appendix A.
"The BioCheck TSH ElA is intended for the quantitative determination of thyrotropin, or thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders."
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K991146
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.