(217 days)
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No
The provided text describes a laboratory test system for measuring thyroxine and contains no mention of AI, ML, or related concepts.
Yes
The device is used in the diagnosis and treatment of thyroid diseases, indicating a therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases." This clearly indicates its use in diagnosis.
No
The summary describes a "total thyroxine test system" intended to measure thyroxine in serum. This strongly implies a physical device that interacts with a biological sample (serum), which is not a software-only device. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only classification.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum." This indicates that the device is used to examine a sample taken from the human body (serum) in vitro (outside the body).
- Diagnostic Purpose: The intended use also states that the measurements are "used in the diagnosis and treatment of thyroid diseases." This clearly indicates a diagnostic purpose, which is a core characteristic of IVDs.
Therefore, the description aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Product codes
KLI
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human figures, possibly representing individuals or communities, with flowing lines suggesting movement or connection. The overall design is simple and conveys a sense of unity and service.
EEB 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mohan Mehra, Ph.D. President Biotecx Laboratories, Inc. 6023 South Loop East Houston, Texas 77033
Re: K982298 Trade Name: OptiCoat T, EIA Kit Regulatory Class: II Product Code: KLI Dated: January 11, 1999 Received: January 12, 1999
Dear Dr. Mehra:
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 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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Ref: 1960
Page 2 of 2
510(k) Number (if known): K982298
Device Name: T4 EIA Kit
Indications For Use:
A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Dean Hooper
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K982298
(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 801.1009)
OR
Over-the-Counter Use
(Optional Format 1-2-96)