(20 days)
Not Found
No
The description details a standard clinical chemistry assay based on enzymatic reactions and spectrophotometric measurement, with no mention of AI or ML.
No
This device is an in vitro diagnostic assay used for the quantitative determination of aspartate aminotransferase, which aids in the diagnosis and treatment of liver and heart disease, but does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease." This indicates the device is used for diagnostic purposes.
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a chemical reaction involving reagents and measurement of absorbance at 340 nm, indicating a physical, chemical-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is used for the "quantitation of aspartate aminotransferase... in human serum and plasma." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples (serum and plasma) outside of the body to provide information for diagnosis and treatment.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay" for the quantitative determination of aspartate aminotransferase. It describes the chemical reactions involved in the assay, which are performed on the sample in a laboratory setting.
- Performance Studies: The "Summary of Performance Studies" describes comparative studies and precision studies conducted on the assay, which are typical evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K861792) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process for medical devices, including IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aspartate Aminotransferase Activated is used for the quantitation of aspartate aminotransferase (also known as a serum glutamic oxaloacetic transferase or SGOT) in human serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Product codes
CIT
Device Description
Aspartate Aminotransferase Activated is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase Activated assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transamination of aspartate and ox-ketoglutarate to produce oxaloacetate and glutamate. Oxaloacetate is subsequently reduced to malate by malate dehydrogenase (MDH) with the concomitant oxidation of NADH to NAD. The rate of NADH oxidation is measured by 340 nm and is proportional to the AST activity of the sample. In addition, this reagent contains lactate dehydrogenase (LD) which consumes endogenous pyruvate during the first four minutes of the incubation period.
Mentions image processing
Not Found
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)
Comparative performance studies were conducted using the ALCYON Analyzer. The Aspartate Aminotransferase assay method comparison yielded acceptable correlation with the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer for the serum application. For the serum application, the correlation coefficient = 0.9983, slope = 0.838, and Y-intercept = - 0.764 U/L. Precision studies were conducted using the Aspartate Aminotransferase Activated assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 5.3% and Level 2/Panel 112 is 2.4%. The Aspartate Aminotransferase Activated assay is linear up to 410 U/L. The limit of quantititation (sensitivity) of the Aspartate Aminotransferase Activated assay is 9 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase Activated assay is substantially equivalent to the performance of the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer for the serum application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9983, slope = 0.838, Y-intercept = - 0.764 U/L, total %CV for Level 1/Panel 111 is 5.3%, total %CV for Level 2/Panel 112 is 2.4%, linear up to 410 U/L, limit of quantititation (sensitivity) is 9 U/L
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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APR 23 1998
510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367
| Date of Preparation of this Summary: | April 2, 1998 |
|---|---|
| Device Trade or Proprietary Name: | AST Activated |
| Device Common/Usual Name or Classification Name: | Aspartate Aminotransferase Activated |
Classification Number/Class:
75CIT/Class II
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
198 1221 The assigned 510(k) number is:
Test Description:
Aspartate Aminotransferase Activated is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase Activated assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transamination of aspartate and ox-ketoglutarate to produce oxaloacetate and glutamate. Oxaloacetate is subsequently reduced to malate by malate dehydrogenase (MDH) with the concomitant oxidation of NADH to NAD. The rate of NADH oxidation is measured by 340 nm and is proportional to the AST activity of the sample. In addition, this reagent contains lactate dehydrogenase (LD) which consumes endogenous pyruvate during the first four minutes of the incubation period.
Section II Page 1
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Substantial Equivalence:
The Aspartate Aminotransferase Activated assay is substantially equivalent to the Boehringer Mannheim® Aspartate Aminotransferase Activated assay on the Hitachi® 717 Analyzer (K861792) for the serum application.
These assays vield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of aspartate . aminotransferase in serum or plasma.
- Both assays yield similar clinical results. .
Differences:
- . There is a minor difference between the assay range.
Intended Use:
The Aspartate Aminotransferase Activated assay is used for the quantitation of aspartate aminotransferase in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Aspartate Aminotransferase assay method comparison yielded acceptable correlation with the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer for the serum application. For the serum application, the correlation coefficient = 0.9983, slope = 0.838, and Y-intercept = - 0.764 U/L. Precision studies were conducted using the Aspartate Aminotransferase Activated assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 5.3% and Level 2/Panel 112 is 2.4%. The Aspartate Aminotransferase Activated assay is linear up to 410 U/L. The limit of quantititation (sensitivity) of the
Section II Page 2
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Aspartate Aminotransferase Activated assay is 9 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase Activated assay is substantially equivalent to the performance of the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer for the serum application.
Conclusion:
The Aspartate Aminotransferase Activated assay is substantially equivalent to the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Aspartate Aminotransferase Activated 510(k) April 1, 1998 ASTAE2.lwp
Section II Page 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its head, body, and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 23 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981221 Re : Aspartate Aminotransferase Activated Requlatory Class: II Product Code: CIT Dated: April 2, 1998 Received: April 3, 1998
Dear Mr. Littlefield:
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 exclosure) 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 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 (301) 443-6597 or at its internet addrass "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
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
5
510(k) Number (if known):
Device Name: Aspartate Aminotransferase Activated
Indications For Use:
The Aspartate Aminotransferase Activated is used for the quantitation of aspartate aminotransferase (also known as a serum glutamic oxaloacetic transferase or SGOT) in human serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
(Division Sign-Off)
Division of Clinical Laboratory Devices
410(k) Number K981221
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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