(31 days)
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No
The summary describes a standard in vitro diagnostic test (EIA) for measuring Free T4, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic test system used for the quantitative determination of free thyroxine in human serum, which aids in the diagnosis and treatment of thyroid diseases. It is a diagnostic tool, not a therapeutic one that treats or prevents disease.
Yes
The "Intended Use / Indications for Use" states that "Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases," which clearly indicates its diagnostic purpose.
No
The device is described as an "in vitro Diagnostic test system" for measuring Thyroxine in human serum. This strongly implies a physical laboratory test kit or analyzer, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states it is an "in vitro Diagnostic test system" and is used for the "quantitative determination of nonprotein-bound (Free) circulating Thyroxine (T4) in human serum." This clearly indicates it is a test performed outside the body on a biological sample (serum) to aid in diagnosis and treatment.
- Intended User / Care Setting: It is described as an "in vitro Diagnostic test system," reinforcing its nature as a diagnostic tool used in a laboratory or clinical setting.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, from the human body to provide information for diagnosis, monitoring, or treatment. The provided information perfectly aligns with this definition.
N/A
Intended Use / Indications for Use
Free T4 EIA can be used as an in vitro Diagnostic test system for the quantitative determination of nonprotein-bound (Free) circulating Thyroxine (T4) in human serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. It is not suitable for use in determination of thyroid status in neonatal patients.
Product codes
CEC
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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§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 4 1998
Jay Singh General Manager Biomerica, Inc. 1533 Monrovia Avenue Newport Beach, California 92663
Re : K982954 Free Thyroxine (FT4) Microwell EIA Regulatory Class: II Product Code: CEC Dated: August 20, 1998 Received: August 24, 1998
Dear Mr. Singh:
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 Requlations, 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 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) 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 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/dsmamain.html".
Sincerely yours,
Steven Ditman
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): K982954
Device Name: Free T4 Microwell EIA
Cat #7019
Indications for use:
Free T4 EIA can be used as an in vitro Diagnostic test system for the quantitative determination of nonprotein-bound (Free) circulating Thyroxine (T4) in human serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. It is not suitable for use in determination of thyroid status in neonatal patients.
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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) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K982954