(117 days)
The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.
Auxiliary product: Pyridoxal Phosphate
Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.
For eCal Calibrator, Nortrol and Abtrol see intended use.
Not Found
The provided submission describes an in vitro diagnostic device (IVD) for the quantitative determination of aspartate aminotransferase (AST/GOT) activity. It is not an AI/ML powered device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set) are not applicable.
Here's the breakdown of the acceptance criteria and study information provided for the AST/GOT (IFCC) device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to those of the predicate device (Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136)). The goal is to demonstrate "substantial equivalence."
| Attribute / Acceptance Criteria (Implied by Predicate) | New Device (AST/GOT (IFCC)) Performance | Predicate Device (Bayer ADVIA IMS AST assay) Performance |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase (L-Aspartate: 2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) activity in human serum or plasma on T60 instrument. | For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase activity in human serum and plasma on the ADVIA Chemistry systems. Such measurements are used mainly to determine the progress and prognosis of patients with myocardial infarction and the diagnosis and monitoring of liver disease. |
| Indication for Use | The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. | See intended use. |
| Assay Protocol | 1-reagent method: Modified IFCC reference method (without PyP) | |
| 3-reagent method: IFCC reference method | 1-reagent method: Modified IFCC | |
| 3-reagent method: IFCC | ||
| Traceability/Standardization | The AST/ GOT (IFCC) 1-reagent method is traceable to the molar absorbance coefficient of NADH. | |
| The AST/ GOT (IFCC) 3-reagent method is traceable to the IFCC reference method. | The ADVIA AST and AST P5P method standardization is traceable to the IFCC reference method via patient sample correlation. | |
| Sample Type | Serum, plasma (heparin) | Serum, plasma (Li-heparin) |
| Reagent Storage | Reagents in unopened vials are stable at 2...8 °C until the expiration date printed on the label when protected from light. | Unopened reagents are stable until the expiration date printed on the product label when stored at 2 - 8°C. |
| Expected Values | Male: |
§ 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.