(286 days)
The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.
For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.
For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.
The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation:
L-Aspartate + 2-Oxoglutarate L-Glutamate + Oxalacetate
Oxalacetate + NADH + H' L-Malate + NAD*
Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P, e.g. from patients with myocardial infarction, liver disease and intensive care patients .
TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.
Trulab N and TruLab P controls-Serum based control serum in normal and pathological range for use in quality control for monitoring accuracy and precision of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.
The furnished document is a 510(k) premarket notification for an in vitro diagnostic device, the DiaSys ASAT (GOT) FS assay, TruCal U calibrator, and TruLab N and TruLab P controls. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive independent clinical study data with predefined acceptance criteria as might be seen for novel devices.
Therefore, the information regarding acceptance criteria and a detailed study proving the device meets these criteria is limited and primarily presented in the context of comparison to the predicate device.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the studies in the same way a clinical trial would. Instead, it presents performance characteristics and compares them to the predicate device, implying that equivalence to the predicate's performance is the de facto acceptance criterion.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (DiaSys ASAT (GOT) FS assay) |
|---|---|---|
| Intended Use | Equivalent to predicate device. | The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. (Similar to predicate, though predicate includes EDTA plasma). |
| Assay Protocol | Equivalent to predicate device. | 2-reagent method: modified IFCC reference method (without P-5-P) or 2-reagent method: IFCC reference method (P-5-P concentrate mixed into R1). (Similar to predicate, predicate uses P-5-P tablet). |
| Traceability | Standardized against IFCC formulation. | Standardized against the original IFCC formulation with and without pyridoxal phosphate. (Same as predicate). |
| Reagent Storage | Comparable shelf life and on-board stability to predicate. | Storage: 2-8°C, Shelf Life R1 - 15 months, R2 - 15 months, P-5-P - 24 months. On Board R1(no P-5-P) - 4 weeks, R1(with P-5-P) - 6 days, R2 - 4 weeks. (Comparable but some differences to predicate). |
| Instrument | Hitachi 917. | Hitachi 917. (Same as predicate). |
| Measuring Range | Comparable to predicate device. | 7-700 U/L. (Predicate: 4-800 U/L). |
| Expected Values | Consistent with clinical understanding and predicate device. | With P-5-P activation: Women |
§ 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.