(23 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring an enzyme level, with no mention of AI or ML technologies.
No
The device is for in vitro diagnostic use to measure aspartate aminotransferase levels, which aids in diagnosing conditions like myocardial infarction and hepatic disease. It does not provide treatment or therapy.
Yes
The device is described for the "quantitative determination of aspartate aminotransferase in serum," where "elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease," indicating its use in identifying disease states.
No
The device is described as an "Aspartate Aminotransferase-SL Assay" for in vitro diagnostic use, which strongly suggests it is a physical assay kit or system, not a software-only device. The description lacks any mention of software components or functions.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For IN VITRO diagnostic use." This is the primary indicator that the device is intended for use outside of the body to diagnose or aid in the diagnosis of a condition.
Furthermore, the description of the device as an "Aspartate Aminotransferase-SL Assay" and its intended use for the "quantitative determination of aspartate aminotransferase in serum" are consistent with the definition of an IVD, which are used to examine specimens such as blood, urine, or tissue to detect diseases or other conditions.
N/A
Intended Use / Indications for Use
For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use.
Elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of AST levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent elevated levels are indicative of diseases of some internal organs.
Product codes
CIT
Device Description
Aspartate Aminotransferase-SL Assay
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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§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 13 1997
Ms. Karen Callbeck, R.T., B.Sc. Regulatory Affairs Coordinator Diagnostic Division Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE, CANADA
Re : K974001 Aspartate Aminotransferase-SL Assay, Trade Name: Catalogue Number 319-10, 319-30 Requlatory Class: I Product Code: CIT Dated: October 15, 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory 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.qov/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): ____________________________________________________________________________________________________________________________________________________
Device Name: Aspartate Aminotransferase-SL Assay
Indications For Use:
For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use.
Elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of AST levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent elevated levels are indicative of diseases of some internal organs.
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- Burtis, C.A., Ashwood, E. R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto pp790-791 (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 pp790-791 (1994).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K94001
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)