(83 days)
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No
The summary describes a quantitative assay for Ammonia in plasma, which is a chemical analysis method and does not mention any AI or ML components.
No.
The device is used for in vitro diagnostic determination of Ammonia in plasma, which aids in diagnosis and treatment but does not directly provide therapy.
Yes
Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, indicating its role in identifying or confirming a disease state.
No
The device description clearly states "Ammonia-L3K @ Assay, Cat. No. 233", which indicates a physical assay kit, not a software-only device. The intended use also describes an "IN VITRO quantitative determination," further suggesting a laboratory test involving physical reagents and equipment.
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 "For the IN VITRO quantitative determination of Ammonia in plasma." The phrase "IN VITRO" is a key indicator of an IVD, meaning the test is performed outside of the living body, typically on biological samples like plasma.
- Device Description: The device is an "Assay," which is a common term for a laboratory test used to measure the amount of a substance in a sample.
- Purpose: The intended use also mentions that the measurements are used in the "diagnosis and treatment of severe liver disorders, such as cirrhosis, and Reye's Syndrome." This indicates the test is used for medical purposes to aid in diagnosis and treatment decisions, which is a core function of IVDs.
N/A
Intended Use / Indications for Use
For the IN VITRO quantitative determination of Ammonia in plasma.
Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma
Product codes (comma separated list FDA assigned to the subject device)
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 (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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§ 862.1065 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 0 2004
Ms. Nancy Olscamp External Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 Mc Carville Street Charlottetown, PE CANADA CIE 2A6
Re: K033921
Trade/Device Name: Ammonia-L-3K® Assay Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I Product Code: JIF Dated: December 17, 2003 Received: January 7, 2004
Dear Ms. Olscamp:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(K) Notification
Diagnostic Chemicals Limited
Ammonia-L3K @ Assay, Cat. No. 233
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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
For the IN VITRO quantitative determination of Ammonia in plasma.
Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma
LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF EEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
A N D / O R
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Per 21 CFR 801.109
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 丈03521