(53 days)
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma. Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome. This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma.
I am sorry, but the provided text from the FDA 510(k) approval letter for the "Randox Ammonia" device does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them.
The document is primarily focused on the FDA's determination of substantial equivalence to a predicate device, which allows the "Randox Ammonia" kit to be marketed. It states the indications for use and mentions the assay's mechanism but does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about sample sizes for test or training sets, data provenance, or expert qualifications.
- Information on ground truth establishment, adjudication methods, or MRMC studies.
Therefore, I cannot extract the specific information you requested from this document.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 2003
Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY
K030873 Re:
Trade/Device Name: Randox Ammonia Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I Product Code: JIF Dated: March 18, 2003 Received: March 20, 2003
Dear Dr.Ambrose:
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,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known)
Unknown
Device Name
Ammonia
Randox Ammonia
Indications For Use :
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma.
Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome.
This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
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)
ean Cooper
ivision Sign-Off) on of Clinical Laborator 5)O(k) Number
§ 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.