(45 days)
For the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use. Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.
Alanine Aminotransferase-SL Assay
This appears to be a 510(k) clearance letter from the FDA for an Alanine Aminotransferase-SL Assay. The document does not describe the acceptance criteria or the specifics of a study conducted to prove the device meets those criteria. Such information is typically found in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested information based on the provided text. The document is essentially an approval letter stating that the device is substantially equivalent to a predicate device. It does not contain the detailed study results or acceptance criteria.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 5 1997
Karen Callbeck, R.T.B.Sc. . Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charolettetown, PE Canada C1E, 1B0
Re : K974003 Alanine Aminotransferase-SL Assay Requlatory Class: T Product Code: CKA Dated: October 17, 1997 Received: October 21, 1997
Dear Ms. Callbeck:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ 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 In addition, FDA may publish further announcements action. 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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K974003/A'
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Alanine Aminotransferase-SL Assay
197400
Indications For Use:
For the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use.
Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.'
-
- Burtis, C.A., Ashwood, E.R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto, p 790-791 (1994).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
- Burtis, C.A., Ashwood, E.R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto, p 790-791 (1994).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Ser-Off)
Division of Clinical Laboratory Laboratory Devices Devices
510(k) Number K974003
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1 - 2-96)
§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.