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510(k) Data Aggregation
(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' < MDH > 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 <31 U/L, Men <35 U/L. Without P-5-P activation: Women <31 U/L, Men <35 U/L. (Predicate: Men up to 40 U/L, Women up to 32 U/L). |
| Precision | Comparable to predicate device. | With P-5-P (N=80): Within Run (Low serum: 1.08%, Middle serum: 1.12%, High serum: 0.93%), Between Run (Low serum: 2.42%, Middle serum: 3.26%, High serum: 0.14%), Total (Low serum: 2.84%, Middle serum: 4.41%, High serum: 1.22%). Without P-5-P (N=80): Within Run (Low serum: 1.32%, Middle serum: 1.13%, High serum: 0.83%), Between Run (Low serum: 3.19%, Middle serum: 3.85%, High serum: 0.57%), Total (Low serum: 3.81%, Middle serum: 5.06%, High serum: 1.30%). (Predicate: Within Run serum: 1.8%, Low: 2.1%, High: 1.1%; Between Run serum: 3.2%, Low: 3.2%, High: 1.8%). Numbers appear comparable or better. |
| Method Comparison | Strong correlation with a commercially available test (predicate). | With P-5-P: $y = 0.975 x + 4.414$ U/L; r2 = 0.9999. (139 serum samples, range 20-639 U/L). Without P-5-P: $y = 1.065 x + 0.215$ U/L; r2 = 0.9994. (139 serum samples, range 12-654 U/L). (Predicate: Passing/Bablock: $y=1.01x-0.93$, Linear regression $y=1.01x-0.75$, r=1.000 for 91 samples, range 11-690 U/L). The r-squared values for the subject device are very high, indicating excellent agreement. |
| Interferences | Recovery within ± 10% of initial value. | Without P-5-P: Interference < 10% by: Ascorbic acid up to 30 mg/dL, Conj. Bilirubin up to 60 mg/dL, Unconj. Bilirubin up to 24 mg/dL, Triglycerides up to 400 mg/dL. With P-5-P: Interference < 10% by: Ascorbic acid up to 30 mg/dL, Conj. Bilirubin up to 36 mg/dL, Unconj. Bilirubin up to 24 mg/dL, Triglycerides up to 400 mg/dL. (Predicate criterion: Hemolysis: 25 mg/dL, Icterus: 60 mg/dL, Lipemia: L index of 500). The ranges for non-interference are reported, showing the device meets these criteria for the tested interferents. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set Sample Size: N=80 for both "With P-5-P" and "Without P-5-P" conditions. The N=80 refers to the total number of measurements, likely across different runs and samples (e.g., low, middle, high serum levels).
- Method Comparison Test Set Sample Size: 139 serum samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document does not specify if the data is retrospective or prospective. Given the nature of a 510(k) for an in vitro diagnostic, these are typically laboratory-based performance studies done on collected human samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable for this type of in vitro diagnostic device. The "ground truth" for the ASAT assay is the quantitative measurement of enzyme activity, which is established by comparison to a reference method (IFCC formulation) or a commercially available, well-established method (the predicate device) on clinical chemistry analyzers, not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This section is not applicable for this type of in vitro diagnostic device, as the performance is based on quantitative measurements rather than qualitative interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically relevant for diagnostic imaging systems where human readers interpret medical images with and without AI assistance. This device is an in vitro diagnostic assay that generates quantitative numerical results, not images for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, the performance studies described (Precision, Method Comparison, Interferences) report the standalone performance of the DiaSys ASAT (GOT) FS assay. This device is an automated assay on a clinical chemistry analyzer (Hitachi 917), meaning its performance is inherently standalone (algorithm/reagent/instrument only) once the sample is loaded. There isn't a "human-in-the-loop" aspect to the analytical measurement process itself, beyond the initial sample preparation and loading.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in these studies is established through either:
- Reference Method Comparison: The ASAT values are traceable to the International Federation of Clinical Chemistry (IFCC) formulation.
- Comparative Device Measurement: For method comparison, the results of the subject device (DiaSys ASAT (GOT) FS assay) are compared against a "commercially available test (x)" on the Hitachi 917, which is the predicate device or a similar established method. This established method's results serve as the comparative "truth."
8. The Sample Size for the Training Set
The document is a 510(k) for a chemical assay, not an AI/machine learning device. Therefore, there is no concept of a "training set" in the context of machine learning. The "development" of the assay involves chemical formulation and calibration, which are different from training an algorithm.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an algorithm, this question is not applicable. The "ground truth" for calibrator values is established through traceability to IFCC standards.
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