(289 days)
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No
The device description details a standard in vitro diagnostic assay based on enzymatic reactions and spectrophotometry, with no mention of AI or ML terms or functionalities.
No
The device is an in vitro diagnostic assay used to measure AST activity for diagnosis, not for treating or preventing disease.
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 that the device's output is intended to aid in diagnosis.
No
The device description clearly indicates this is an in vitro diagnostic assay involving chemical reactions and measurement of absorbance, which are hardware-dependent processes. It is not solely software.
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 "intended to measure the activity of the enzyme aspartate aminotransferase (AST) ... in serum and plasma." It also mentions that these measurements are "used in the diagnosis and treatment of certain types of liver and heart disease." This clearly indicates that the device is used to analyze biological samples (serum and plasma) in vitro (outside the body) for diagnostic purposes.
- Device Description: The "Device Description" further reinforces this by describing the assay as an "in vitro diagnostic assay for the quantitation of aspartate aminotransferase... in human serum or plasma." It details the chemical reactions that occur in vitro to measure the enzyme activity.
- Performance Studies: The performance studies described involve analyzing samples and comparing the results to a predicate device, which is typical for IVD submissions.
The core function of the device is to perform a test on a biological sample in vitro to provide information for diagnosis and treatment, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Abbott Laboratories Activated AST assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Aspartate Aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are 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
Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
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)
Comparative performance studies were conducted using the AEROSET and ARCHITECT cSystems. The Abbott Laboratories Activated AST assay, LN 08L91, method comparison yielded acceptable correlation between the following reagent/instrument comparisons:
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- Abbott Laboratories Activated AST assay on the AEROSET vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
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- Abbott Laboratories Activated AST on the ARCHITECT c8000 vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
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- Abbott Laboratories Activated AST on the ARCHITECT c16000 System vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
Results consisted of:
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- The Abbott Laboratories Activated A.ST assay on the Abbott AEROSET System showed a correlation coefficient of 0.999, slope of 1.06, and Y-intercept of 3.79 U/I . when compared to the Predicate Device.
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- The Abbott Laboratories Activated AST on the ARCHITECT c8000 System showed a correlation coefficient of 0.999, slope of 1.01, and Y-intercept of -4.15 U/L when compared to the Predicate Device.
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- The Abbott Laboratories Activated AST on the ARCHITECT c16000 System showed a correlation coefficient of 0.999, slope of 1.03, and Y-intercept of -3.75 U/L when compared to the Predicate Device.
The Abbott Laboratories Activated AST assay run on the Abbott AEROSET and ARCHITECT cSystems method comparison results yielded acceptable correlation to the Abbott AST Activated assay on the Abbott AEROSET System.
Precision studies were conducted using the Abbott Laboratories Activated AST assay. On the ARCHITECT c8000 System, the 20 Day total %CV for Level 1 (43 U/L) is 4.5%, and Level 2 (192 U/L) is 1.0% and the 5 Day total %CV for Level 3 (23 U/L) is 2.4% and Level 4 (3,437 U/L) is 0.7%. On the AEROSET System, the 5 Day total %CV for Level 1 (46 U/L) is 2.3% and Level 2 (205 U/L) is 0.7%. On the ARCHITECT c16000 System, the 5 Day total %CV for Level 1 (45 U/L) is 1.8% and Level 2 (197 U/I.) is 0.5%.
The Abbott Laboratories Activated AST assay is linear up to 1,985 U/L. The limit of quantitation of the Abbott Laboratories Activated AST assay is 5 U/L, with Flex Rate linearity up to 5,364 U/L.
These data demonstrate that the performance of the Abbott Laboratories Activated AST assay is substantially equivalent to the performance of the Abbott AST Activated assay, I.N 08D37 (K981221) on the AEROSET and ARCHITECT cSystems.
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.
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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K07/525
MAR 1 9 2008
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038
Contact Person Linda Morris Senior Regulatory Specialist, MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-7479
| Date of Preparation of this Summary: | May 31, 2007
Updated March 17, 2008 |
|-----------------------------------------------------|-----------------------------------------|
| Device Trade or Proprietary Name: | Activated Aspartate
Aminotransferase |
| Device Common/Usual Name or
Classification Name: | Activated AST |
| Classification Number/Class: | Class II / 862.1100 |
| Product Code: | CIT |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 862.1100.
K071525 The assigned 510(k) number is:
Test Description:
Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
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Substantial Equivalence:
The Abbott Laboratories Activated AST assay on the Abbott AEROSET and ARCHITECT cSystems is substantially equivalent to the Abbott AST Activated (K981221) assay on the AERO$ET System. Both assays yield similar Performance Characteristics.
Similarities:
- Both assays use NADH (with P-5'-P) methodology .
- . Both assays can be used for the quantitation of AST
- . Both assays yield similar results
- Both assays use serum and plasma .
Differences:
Abbott Laboratories Activated Aminotransferase is a liquid reagent. Aspartate Aminotransferase Activated is a lyophilized reagent requiring reconstitution prior to use.
Intended Use:
The Abbott Laboratories Activated AST assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Aspartate Aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET and ARCHITECT cSystems. The Abbott Laboratories Activated AST assay, LN 08L91, method comparison yielded acceptable correlation between the following reagent/instrument comparisons:
Next Generation Activated AST 510(k) March 17, 2008
Section II Page 2
2
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- Abbott Laboratories Activated AST assay on the AEROSET vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
-
- Abbott Laboratories Activated AST on the ARCHITECT c8000 vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
-
- Abbott Laboratories Activated AST on the ARCHITECT c16000 System vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
Results consisted of:
-
- The Abbott Laboratories Activated A.ST assay on the Abbott AEROSET System showed a correlation coefficient of 0.999, slope of 1.06, and Y-intercept of 3.79 U/I . when compared to the Predicate Device.
-
- The Abbott Laboratories Activated AST on the ARCHITECT c8000 System showed a correlation coefficient of 0.999, slope of 1.01, and Y-intercept of -4.15 U/L when compared to the Predicate Device.
-
- The Abbott Laboratories Activated AST on the ARCHITECT c16000 System showed a correlation coefficient of 0.999, slope of 1.03, and Y-intercept of -3.75 U/L when compared to the Predicate Device.
The Abbott Laboratories Activated AST assay run on the Abbott AEROSET and ARCHITECT cSystems method comparison results yielded acceptable correlation to the Abbott AST Activated assay on the Abbott AEROSET System.
Precision studies were conducted using the Abbott Laboratories Activated AST assay. On the ARCHITECT c8000 System, the 20 Day total %CV for Level 1 (43 U/L) is 4.5%, and Level 2 (192 U/L) is 1.0% and the 5 Day total %CV for Level 3 (23 U/L) is 2.4% and Level 4 (3,437 U/L) is 0.7%. On the AEROSET System, the 5 Day total %CV for Level 1 (46 U/L) is 2.3% and Level 2 (205 U/L) is 0.7%. On the ARCHITECT c16000 System, the 5 Day total %CV for Level 1 (45 U/L) is 1.8% and Level 2 (197 U/I.) is 0.5%.
3
The Abbott Laboratories Activated AST assay is linear up to 1,985 U/L. The limit of quantitation of the Abbott Laboratories Activated AST assay is 5 U/L, with Flex Rate linearity up to 5,364 U/L.
These data demonstrate that the performance of the Abbott Laboratories Activated AST assay is substantially equivalent to the performance of the Abbott AST Activated assay, I.N 08D37 (K981221) on the AEROSET and ARCHITECT cSystems.
Conclusion :
The Abbott Laboratories Activated AST assay on the AEROSET System and ARCHITECT cSystems is substantially equivalent to the Abbott AST Activated assay, LN 08D37 (K981221) on the AEROSET System and ARCHITECT cSystems as demonstrated by results obtained in the studies.
Next Generation Activated AST 510(k) March 17, 2008
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Abbot Laboratories c/o Ms. Linda Morris Senior Regulatory Specialist 1920 Hurd Drive Irving, TX 75038
MAR 1 9 2008
Re: K071525
Trade/Device Name: Next Generation Activated Asparate Aminotransferase Assay Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system. Regulatory Class: Class II Product Code: CIT Dated: March 10, 2008 Received: March 11, 2008
Dear Ms. Morris:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 011525
Device Name: _ Abbott Laboratories Activated Aspartate Aminotransferase
Indications For Use:
Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
L.vision Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
4071525
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