(277 days)
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No
The summary describes a standard laboratory chemistry analyzer and ELISA kits for thyroid hormone testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the chemical analysis of blood samples.
No
The device is used for diagnosis of thyroid disorders by measuring hormones from patient serum samples, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurement of the hormones obtained by this device "is used for the diagnosis of thyroid disorders."
No
The description clearly states the device is used to "obtain blood chemistry information from patient serum samples" and mentions "ELISA kits," which are hardware components used in laboratory testing. This indicates the device is a system that includes hardware, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device will be used to "obtain blood chemistry information from patient serum samples" and that the measurements are used for the "diagnosis of thyroid disorders." This aligns directly with the definition of an IVD, which are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Specimen Type: The device uses "patient serum samples," which are biological specimens derived from the human body.
- Diagnostic Purpose: The results obtained from the device are used for the "diagnosis of thyroid disorders."
Therefore, based on the provided information, the ChemWell device is clearly intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.
Product codes
JLW; CDP; KLI
Device Description
ChemWell, also known as project 2900, used for United Biotech, Inc. (UBI) kits.
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
laboratory technologists
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings forming three curved lines. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 9 2002
Mr. Glen Van Slooten Research Chemist Awareness Technology, Inc. 1995 S.W. Martin Hwy. P.O. Box 1679 Palm City, FL 34990
Re: K013420
Trade/Device Name: ChemWell, also know as project 2900, used for United Biotech, Inc. (UBI) kits Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW; CDP; KLI` Dated: May 8, 2002 Received: May 9, 2002
Dear Mr. Van Slooten:
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, 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 (PMA), 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 898. 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 Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.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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510 (k) Number: K013420
Device Name: ChemWell, also known as project 2900, used for United Biotech. Inc. (UBI) kits.
Indications For Use: ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.
Sean Coopn
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KO13420°
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use