(20 days)
Not Found
No
The device description and performance studies describe a standard clinical chemistry assay based on enzymatic reaction and spectrophotometry, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for the quantitation of aspartate aminotransferase, which aids in the diagnosis and treatment of certain diseases, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is used in the diagnosis and treatment of certain types of liver and heart disease."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a chemical reaction involving the oxidation of NADH and measurement of absorbance at 340 nm. This indicates a physical chemical process, not a software-only function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitation of aspartate aminotransferase in human serum or plasma" and that this measurement is used in the "diagnosis and treatment of certain types of liver and heart disease." This clearly indicates a diagnostic purpose using biological samples.
- Device Description: The description further clarifies it's an "in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma." The method described (measuring absorbance changes in a chemical reaction) is a typical in vitro diagnostic technique.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K861792) and name ("Boehringer Mannheim® AST assay") strongly suggests this device is being compared to an already cleared IVD device, which is a common regulatory pathway for new IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aspartate Aminotransferase assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Measurement of aspartate aminotransferase is used in the diagnosis and treatment of certain types of liver and heart disease.
Product codes (comma separated list FDA assigned to the subject device)
CIT
Device Description
Aspartate Aminotransferase is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase assay is a clinical chemistry assay in which NADH is oxidized to NAD. The resulting decrease in absorbance at 340 nm is indicative of the presence of aspartate aminotransferase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET™ System. The Aspartate Aminotransferase assay method comparison vielded acceptable correlation with the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.999, slope = 0.893 and Y-intercept = -1.815 U/L. Precision studies were conducted using the Aspartate Aminotransferase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 1.6% and Level 2/Panel 102 is 1.2%. The Aspartate Aminotransferase assay is linear up to 4,202 U/L. The limit of quantitation (sensitivity) for the Aspartate Aminotransferase assay is 1.5 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase assay is substantially equivalent to the performance of the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.999, slope = 0.893 and Y-intercept = -1.815 U/L. The total %CV for Level 1/Panel 101 is 1.6% and Level 2/Panel 102 is 1.2%. The Aspartate Aminotransferase assay is linear up to 4,202 U/L. The limit of quantitation (sensitivity) for the Aspartate Aminotransferase assay is 1.5 U/L.
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.
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.
Not Found
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).
Not Found
§ 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.
0
2983131
SEP 28 1998
510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | September 4, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Aspartate Aminotransferase |
| Device Common/Usual Name or Classification Name: | AST |
| Classification Number/Class: | 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.
The assigned 510(k) number is: 183131
Test Description:
Aspartate Aminotransferase is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase assay is a clinical chemistry assay in which NADH is oxidized to NAD. The resulting decrease in absorbance at 340 nm is indicative of the presence of aspartate aminotransferase.
Substantial Equivalence:
The Aspartate Aminotransferase assay is substantially equivalent to the following device:
Boehringer Mannheim® AST assay (K861792) on the Hitachi® 717 Analyzer . Both assays yield similar Performance Characteristics.
Aspartate Aminotransferase 510(k) September 4, 1998 Ast
Section II Page 1
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1
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- . Both assays can be used for the quantitative determination of AST.
- . Both assays vield similar clinical results.
- Both assays are based on the oxidation of NADH to NAD. .
Differences:
- . There is a difference between the assay range.
Intended Use:
The Aspartate Aminotransferase assay is used for the quantitation of aspartate aminotransferase in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Aspartate Aminotransferase assay method comparison vielded acceptable correlation with the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.999, slope = 0.893 and Y-intercept = -1.815 U/L. Precision studies were conducted using the Aspartate Aminotransferase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 1.6% and Level 2/Panel 102 is 1.2%. The Aspartate Aminotransferase assay is linear up to 4,202 U/L. The limit of quantitation (sensitivity) for the Aspartate Aminotransferase assay is 1.5 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase assay is substantially equivalent to the performance of the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer.
Aspartate Aminotransferase 510(k) September 4, 1998 Ast
Section II Page 2
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 28 1998
Linda Morris .Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038
Re : K983131 Aspartate Aminotransferase Regulatory Class: II Product Code: CIT Dated: September 4, 1998 Received: September 8, 1998
Dear Ms. Morris:
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 regulations 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 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 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
4
510(k) Number (if known): $983|3| ___
Device Name:
Indications For Use:
The Aspartate Aminotransferase assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Measurement of aspartate aminotransferase is used in the diagnosis and treatment of certain types of liver and heart disease.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | k 9831 31 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concyrence of CDRH, Office of Device Evaluation (ODE) Prescription Use / Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)