(47 days)
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No
The provided 510(k) summary describes a quantitative immunoassay for triiodothyronine (T3) and contains no mention of AI or ML technology.
No
The device is intended for the quantitative determination of T3 in human serum for diagnostic purposes, not for treatment.
Yes
The intended use explicitly states, "This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism," which signifies its diagnostic purpose.
No
The 510(k) summary describes an EIA (Enzyme Immunoassay) test, which is a laboratory diagnostic method involving chemical reagents and physical processes to measure substances in biological samples. This inherently involves hardware (e.g., microplates, readers, pipettes) and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The key phrase that indicates this is an IVD is:
"The BioCheck Total T3 EIA is intended for the quantitative determination of triiodothyronine (T3) in human serum."
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device clearly fits this description as it is used to measure a substance (T3) in a human sample (serum) for the purpose of diagnosing and treating thyroid diseases.
N/A
Intended Use / Indications for Use
The BioCheck Total T3 EIA is intended for the quantitative determination of triiodothyronine (T3) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
Product codes
CDP
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
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Key Metrics
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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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§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1999
Biocheck, Inc. C/O Robin J. Hellen, M. S. Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325
Re: K991311
Trade Name: BioCheck Total T3 Enzyme Immunoassay Test Kit Regulatory Class: II Product Code: CDP Dated: May 21, 1999 Received: May 24, 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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PART I - 510(k) Inform
III. Statement for Indications for Use
| 510(k) Number (if known): | K991311 |
|---|---|
| Device Name: | BioCheck, Inc. Total T3 Enzyme Immunoassay Test Kit |
| Indications for Use: |
The BioCheck Total T3 EIA is intended for the quantitative determination of triiodothyronine (T3) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
| | (Division Sign-Off)
Division of Clinical Laboratory Devices |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K991311 |
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | OR | Over the Counter Use: | |
|---|---|---|---|
| ------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---- | ----------------------- |