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510(k) Data Aggregation
(286 days)
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
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 |
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(44 days)
AST (SGOT)
Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers.
Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Not Found
This document is a 510(k) clearance letter for an in vitro diagnostic device, the AST (SGOT) REAGENT. It is a regulatory approval, not a scientific study report. Therefore, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study.
The document only states the "Indications for Use":
Device Name: AST (SGOT) REAGENT
Indications for Use: Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
To answer your request, a separate study report or a more detailed filing from JAS Diagnostics, Inc. to the FDA would be needed. This letter primarily confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
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(47 days)
AST/SGOT
The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro determination of AST (SGOT) in serum, or plasma.
Not Found
This document is a 510(k) clearance letter from the FDA for a device named "AST (SGOT)". The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. However, this letter does not contain specific acceptance criteria or details of a study proving the device meets those criteria in the way a clinical trial report or performance study summary would.
Therefore, I cannot provide the requested information from the given text because the document is a regulatory clearance letter, not a detailed performance study report.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The letter states the device is "substantially equivalent," which is the regulatory hurdle, but doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity, or precision) that would be acceptance criteria, nor does it list the specific results of a study against such criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size & Ground Truth Establishment: These are all details typically found in a clinical study report or a 510(k) summary (which sometimes includes more detail than the clearance letter itself). This letter only grants clearance based on the submission, it doesn't contain the specifics of that submission's performance data.
The "Indications For Use" section on page 2 simply states the device's intended use: "The AST (SGOT) reagents... are intended for In vitro determination of AST (SGOT) in serum, or plasma." This describes what the device does, not how well it does it or the data proving its performance.
To answer your questions, one would need to review the actual 510(k) submission (including the summary of safety and effectiveness data) that the FDA reviewed to make this substantial equivalence determination, not just the clearance letter.
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(49 days)
AST/SGOT LIQUID REAGENT - KINETIC METHOD
For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases.
AST/SGOT LIQUID REAGENT - KINETIC METHOD
The provided document is a 510(k) clearance letter from the FDA for an AST/SGOT Liquid Reagent - Kinetic Method device. This type of document does not typically contain the detailed study information or acceptance criteria as outlined in your request for AI/diagnostic imaging devices.
The 510(k) clearance process demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria in the same way newer, high-risk devices or AI-driven diagnostics do.
Therefore, I cannot extract the specific information you've requested from these pages. The document confirms:
- Device Name: AST/SGOT LIQUID REAGENT - KINETIC METHOD
- Intended Use: "For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases."
To answer your questions about acceptance criteria and study data, one would typically need access to the 510(k) submission document itself, which would include performance data from the manufacturer's internal studies comparing their device to the predicate. This information is not present in the FDA's clearance letter.
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(25 days)
AST/SGOT
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