(22 days)
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No
The summary does not mention AI, ML, or any related terms, and the device description "Ammonia-Incorporating Dynamic Stabilization Technology (DST)" does not inherently suggest AI/ML.
No
Explanation: The device is intended for in vitro diagnostic (IVD) use to quantify ammonia in human plasma, which is used for diagnosis and treatment monitoring, not for direct therapeutic intervention.
Yes
The device is described as being used for the "diagnosis and treatment of severe liver disorders" by measuring Ammonia, indicating a diagnostic purpose.
No
The device description "Ammonia-Incorporating Dynamic Stabilization Technology (DST)" and the intended use for "In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems" strongly suggest a laboratory or analytical instrument, which would involve hardware components for sample handling, analysis, and measurement. There is no mention of the device being solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma". "In Vitro" means outside of the living body, which is a key characteristic of IVDs.
- Sample Type: The device analyzes "human plasma", which is a biological sample taken from a patient.
- Purpose: The measurements are used in the "diagnosis and treatment of severe liver disorders". This indicates a medical purpose related to diagnosing or monitoring a disease.
- CFR Reference: The mention of "CFR 862.1065" is a strong indicator. This is the Code of Federal Regulations section that specifically defines and classifies Ammonia test systems as a Class II IVD.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for the the In Vitro, quantitative determination of Ammonia (NH₃) in human plasma on automated systems. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome.
Product codes
JIF
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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§ 862.1065 Ammonia test system.
(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.
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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 consists of a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
JAN - 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Johnston Technical Director TRACE America, Inc. 7260 N.W. 58th Street Miami, Florida 33166
K974620 Re:
Trade Name: Ammonia-Incorporating Dynamic Stabilization Technology (DST) Regulatory Class: I Product Code: JIF Dated: June 6, 1997 Received: December 11, 1997
Dear Mr. Johnston:
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 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 OS 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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): K974620 Device Name: Ammonia (DST) Indications for Use:
Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems.
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome. " CFR 862.1065
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF ( NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.H. M. Awram
(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number. K974620
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)