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510(k) Data Aggregation
(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.
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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 IFCC3-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: < 35 U/lFemale: < 31 U/l | 1-reagent method: < 34 U/l3-reagent method: 13-40 U/l |
| Instrument | T60 and DPC T60i, DPC T60i Kusti | ADVIA® 1650 Chemistry system. |
| Measuring Range | 1-reagent method: 4 – 350 U/l3-reagent method: 4 - 300 U/l | 0 - 1000 U/l |
| Precision (Within run, Between run, Total CV%) | 1-reagent method:Within run: 38 U/l (SD=0.5, CV=1.4%), 101 U/l (SD=0.9, CV=0.9%), 189 U/l (SD=1.0, CV=0.5%)Between run: 101 U/l (SD=0.5, CV=0.5%), 189 U/l (SD=1.1, CV=0.6%)Total: 38 U/l (SD=0.9, CV=2.4%), 101 U/l (SD=2.0, CV=2.0%), 189 U/l (SD=3.2, CV=1.7%)3-reagent method:Within run: 37 U/l (SD=0.6, CV=1.5%), 124 U/l (SD=1.3, CV=1.1%), 191 U/l (SD=1.0, CV=0.5%)Between run: 37 U/l (SD=0.4, CV=1.0%), 124 U/l (SD=1.4, CV=1.1%), 191 U/l (SD=1.2, CV=0.6%)Total: 37 U/l (SD=1.0, CV=2.7%), 124 U/l (SD=2.5, CV=2.0%), 191 U/l (SD=2.9, CV=1.5%) | 1-reagent method:Within run: 42 U/l (SD=0.8, CV=2.1%), 188 U/l (SD=1.3, CV=0.7%)Total: 42 U/l (SD=1.3, CV=3.3%), 188 U/l (SD=4.1, CV=2.3%)3-reagent method:Within run: 50 U/l (SD=0.6, CV=1.5%), 195 U/l (SD=1.3, CV=1.1%)Total: 50 U/l (SD=1.0, CV=2.7%), 195 U/l (SD=2.5, CV=2.0%) |
| Method Comparison (Correlation with Predicate/Reference Method) | 1-reagent method: $y = 0.95x - 2.0$, R = 0.992 (Range 12 to 307 U/L, N=83)3-reagent method: $y = 0.94x + 1.3$, R = 0.994 (Range 15 to 408 U/L, N=84) | Comparison with Technicon DAX: $y = 0.99x - 6.3 U/l$, r = 0.999 (n = 111, range: 9.8 to 607.2 U/l) |
| Limitations (Interference) | 1-reagent method:Lipemia: No interference up to 150 mg/dL (1.5 g/l) Intralipid.Hemolysate: Avoid hemolyzed samples.Bilirubin, conjugated: No interference up to 35 mg/dL (600 µmol/l).Bilirubin, unconjugated: No interference up to 35 mg/dL (600 µmol/l).3-reagent method:Lipemia: No interference up to 150 mg/dL (1.5 g/l) Intralipid.Hemolysate: Avoid hemolyzed samples.Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l).Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l). | 1-reagent method:Lipemia (Intralipid): No significant interference up to 488 mg/dl.Hemolysate: Avoid hemolyzed samples.Bilirubin (conjugated and unconjugated): No significant interference up to 30 mg/dl (513 µmol/l).3-reagent method (AST Sample Concentration 65 U/l):Lipemia (Intralipid): No significant interference up to 488 mg/dl.Hemolysate: Avoid hemolyzed samples.Bilirubin (conjugated and unconjugated): No significant interference up to 30 mg/dl (513 µmol/l). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison:
- 1-reagent method: N = 83 (samples)
- 3-reagent method: N = 84 (samples)
- Precision studies involve multiple measurements at different concentration levels, typically using control materials, but the exact number of individual patient samples for a "test set" demonstrating general performance is not explicitly stated beyond the method comparison.
- Method Comparison:
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Thermo Fisher Scientific Oy is based in Finland, it is plausible that some studies were conducted there. The context of a 510(k) submission implies that the data would be collected to support the safety and effectiveness for a US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as this is an in vitro diagnostic (IVD) device (a laboratory test), not an AI/ML diagnostic imaging device that requires expert interpretation for ground truth. The "ground truth" for IVDs is typically established by reference methods or validated comparative analyses, not expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable for an IVD device. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as this is an IVD device and not an AI/ML-powered diagnostic imaging or interpretation system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is an IVD device, which inherently operates as a "standalone" test (algorithm only in the sense of the chemical reactions and measurement, without human interpretive input for the result itself). The device's performance is measured directly by its analytical accuracy, precision, and agreement with reference methods.
7. The Type of Ground Truth Used
The ground truth for this type of IVD device is established through:
- Reference Methods: The device's performance is compared against established reference methods, such as the IFCC reference method or the predicate device (Bayer ADVIA IMS AST assay), which serves as a clinical comparison.
- Traceability to Standards: The 1-reagent method is traceable to the molar absorbance coefficient of NADH, and the 3-reagent method is traceable to the IFCC reference method.
- Known Concentrations: Precision studies involve testing samples with known or controlled concentrations of the analyte.
8. The Sample Size for the Training Set
This information is not applicable as this is a chemical assay, not an AI/ML model that requires a "training set." The assay method is based on established chemical principles and does not "learn" from data in the way an AI algorithm does.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the context of this IVD device.
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