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510(k) Data Aggregation
(408 days)
JAS Diagnostics, Inc.
The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.
The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell Carcinoma.
The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.
The instrument includes of the following main parts;
- . Sampling Arm (for sample addition to cuvettes)
- Reagent Arm (for reagent addition to cuvettes) .
- Reaction Station (cuvettes) .
- Sample Plate Station (for loading samples) .
- Reagent Plate Station (for on board reagents) .
- . Photometer (for reaction analysis reading)
- Wash Station (for cleaning of reaction cuvettes) .
- Electronic Boards (for controlling the open functions) .
The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.
The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.
Here's a breakdown of the acceptance criteria and study information for the JAS XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, and ISE Reagent Pack, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials. Therefore, information regarding human reader studies (MRMC), standalone AI performance, and expert qualifications for ground truth in the traditional sense of AI/ML studies are not typically found in these submissions as the device is not an AI/ML diagnostic tool. The "ground truth" here refers to established, validated reference methods or materials in clinical chemistry.
1. Table of Acceptance Criteria and Reported Device Performance
Device: XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Tests: Glucose, Sodium, Potassium, Chloride
| Performance Characteristic | Acceptance Criteria (Implicit from Results) | Reported Device Performance (Glucose) | Reported Device Performance (Sodium) | Reported Device Performance (Potassium) | Reported Device Performance (Chloride) |
|---|---|---|---|---|---|
| Linearity | Data linear within allowable nonlinearity (e.g., 3mg/dL or 5%) | 9 to 500 mg/dL | 100 to 200 mEq/L | 1.0 to 10.0 mEq/L | 50 to 150 mEq/L |
| Slope between 0.90 and 1.10 | 1.001 (Glucose linearity) | - | - | - | |
| Intercept close to 0 mg/dL | -0.1 mg/dL (Glucose linearity) | - | - | - | |
| Calibrator Traceability Accuracy | "Accuracy test passed and results linear" with acceptable slope and intercept. | Slope: 0.972, Intercept: 2.1mg/dL, Error: 1.4% | Slope: 1.007, Intercept: 4.4mmol/L, Error: 0.1% | Slope: 0.902, Intercept: 0.1mmol/L, Error: 1.3% | Slope: 1.012, Intercept: 2.0mmol/L, Error: 1.3% |
| Interferences | Glucose values remain within 10% of unspiked sample value. | Hemoglobin: up to 400 mg/dLBilirubin: up to 21.4 mg/dLLipemia: up to 412 mg/dLAscorbic Acid: up to 10.0 mg/dL | Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL | Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL | Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL |
| Method Comparison (Correlation) | R > 0.95, Slope between 0.90 and 1.10, Intercept close to 0 | R: 0.9970, Slope: 1.002, Intercept: 1.8 mg/dL (vs. Olympus 400 Glucose Reagent) | R: 0.9917, Slope: 0.984, Intercept: 2.256 mmol/L (vs. Olympus 400 ISE) | R: 0.9954, Slope: 0.999, Intercept: 0.05 mmol/L (vs. Olympus 400 ISE) | R: 0.9856, Slope: 1.070, Intercept: -4.3 mmol/L (vs. Olympus 400 ISE) |
| Precision/ Reproducibility (CV%) | CV (%) |
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(257 days)
JAS Diagnostics, Inc.
For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only.
For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.
Not Found
This document is a 510(k) premarket notification acceptance letter from the FDA for medical devices: "Cholesterol Oxidase JAS" and "Glycerol Kinase Triglycerides." This type of document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness (SSE). The 510(k) essentially states that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
Therefore, I cannot extract the requested information from the provided text because it is not present in this regulatory acceptance letter. This document is not a study report.
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(79 days)
JAS Diagnostics, Inc.
This product is to be used for the quantitative determination of glucose oxidase in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia and of pancreatic islet cell carcinoma. This reagent set is intended for in vitro diagnostic use only.
This product is to be used for the quantitative determination of hemoglobin A 1 c in human blood. The determination of hemoglobin A 1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A 1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A 1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
This product is to be used for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
Not Found
I am sorry, but the provided text is a 510(k) summary from the FDA, which is a regulatory document and does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. This document primarily outlines the substantial equivalence determination for the JAS Diagnostics Fructosamine, Glucose Oxidase, and Hemoglobin A1c test kits to legally marketed predicate devices.
Therefore, I cannot extract the information required to fill out the table and answer the questions.
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(62 days)
JAS Diagnostics, Inc.
Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers.
LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
Not Found
This document is a 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically an "LDL Cholesterol (Automated) Reagent." The letter indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness.
Here's a breakdown based on the provided text, highlighting what's not present:
Missing Information: The core request for acceptance criteria and a study demonstrating performance is not addressed in this regulatory clearance letter. This type of letter acknowledges substantial equivalence but does not delve into the specifics of performance studies.
Despite the limitations, I will attempt to answer each point, noting when the information is unavailable in the provided text.
Acceptance Criteria and Device Performance Study Information
This 510(k) clearance letter does not provide the acceptance criteria or detailed results of a performance study for the LDL Cholesterol (Automated) Reagent. The letter is a regulatory document indicating substantial equivalence to a legally marketed predicate device, rather than a technical report on the device's performance characteristics.
Therefore, the following table and subsequent sections will largely indicate "Not provided in the text" for the requested details.
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not Specified in Document | Not provided in the text | Not provided in the text |
| (e.g., Accuracy, Precision, Linearity, Interference, Method Comparison with Reference Method) | Not provided in the text | Not provided in the text |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided in the text.
- Data Provenance: Not provided in the text (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided in the text. For IVD devices like a cholesterol reagent, ground truth is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the same way as imaging or pathological diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided in the text. Adjudication methods are typically used in studies involving human interpretation (e.g., imaging, clinical diagnoses) rather than quantitative laboratory assays.
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
- Not applicable. This device is an automated reagent for quantitative determination of LDL Cholesterol, not an AI-assisted diagnostic imaging or interpretative tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device described, "LDL Cholesterol (Automated) Reagent," is inherently a standalone (algorithm/reagent only) system for quantitative measurement. The concept of "human-in-the-loop" assistance, as typically applied to AI, does not directly apply here. The performance of the reagent is evaluated on its ability to accurately measure LDL cholesterol without human interpretation affecting the result generation itself. However, the specific study details confirming this standalone performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in the provided text. For an LDL Cholesterol assay, the ground truth would typically be established by a recognized reference method (e.g., CDC reference method for cholesterol, ultracentrifugation, or isotope dilution-mass spectrometry) or by a highly validated predicate device.
8. The sample size for the training set
- Not applicable/Not provided in the text. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense. Performance is evaluated through analytical and clinical validation studies using patient samples.
9. How the ground truth for the training set was established
- Not applicable/Not provided in the text, as this is not an AI/ML device with a "training set."
Summary of Document Content:
The provided document is an FDA 510(k) clearance letter for the JAL Diagnostics, Inc. LDL Cholesterol (Automated) Reagent. Key information from the letter includes:
- Device Name: LDL Cholesterol (Automated) Reagent
- Indications for Use: Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. Used in the diagnosis and treatment of disorders involving high LDL Cholesterol, associated with increased risk of coronary heart disease.
- Regulatory Status: Class I device, Product Code: MRR; JHM; JIX; JJY. Found substantially equivalent to a legally marketed predicate device.
- Clearance Date: September 30, 2002.
Conclusion:
This 510(k) clearance letter confirms that the FDA found the device "substantially equivalent" to existing predicate devices, allowing it to be marketed. However, it does not include the detailed technical data, performance acceptance criteria, or specific study results that would typically be contained within a device's 510(k) submission summary or a separate performance study report. This kind of detail is usually found in the original 510(k) submission, which is not provided here.
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(59 days)
JAS Diagnostics, Inc.
Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers.
HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "HDL Cholesterol (Automated) REAGENT." This document primarily covers the regulatory approval of the device and does not contain the specific technical details about acceptance criteria or the study used to prove the device meets them.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a scientific study report or a detailed submission outlining performance characteristics.
To answer your questions, I would need to analyze a different type of document, such as:
- A summary of safety and effectiveness from the 510(k) submission.
- The applicant's performance study report.
- The labeling/instructions for use for the device, which often contains performance characteristics.
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(56 days)
JAS Diagnostics, Inc.
Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Chemistry Calibrator. This device is a calibrator intended for use in calibrating multiple in vitro quantitative chemistry assays on automated chemistry analyzers.
Based on the information provided, this document addresses a diagnostic device that performs calibration, not an AI/ML-driven device or study evaluating human reader performance. Therefore, most of the requested information (acceptance criteria, device performance metrics, study design elements for AI/ML, human reader studies, etc.) is not applicable or extractable from this regulatory document.
However, I can extract information related to the device type and its intended use.
1. A table of acceptance criteria and the reported device performance
- This document does not contain any acceptance criteria or reported device performance data. It is a regulatory clearance letter, not a performance study report. For a calibrator, acceptance criteria would typically involve accuracy, precision, linearity, and stability, but these are not present here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a clinical study or a test set as defined for AI/ML performance evaluation. Calibrator performance is typically evaluated by methods like linearity, recovery studies, and value assignment, not through test sets with human specimens in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of calibrators refers to the accurately assigned values for the analytes within the calibrator, which are established through certified reference materials and rigorous analytical methods, not typically by expert consensus in the diagnostic sense implied by the question.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No. This device is a chemical calibrator, not an AI/ML diagnostic algorithm that would be used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical chemical calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a chemical calibrator, the "ground truth" for its assigned values would be established through traceability to internationally recognized reference materials and/or methods, often involving multiple reference laboratories and certified analytical techniques. This is a metrological concept, distinct from clinical ground truth like pathology or expert consensus. The document does not specify how the values for this particular calibrator were established.
8. The sample size for the training set
- Not applicable. There is no "training set" for a chemical calibrator in the sense of AI/ML.
9. How the ground truth for the training set was established
- Not applicable.
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(31 days)
JAS Diagnostics, Inc.
Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers.
Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Amylase Reagent" device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter primarily:
- Confirms that the device is substantially equivalent to a legally marketed predicate device.
- Outlines the regulatory requirements for the device.
- Grants permission to market the device.
- Provides contact information for regulatory inquiries.
The "Indications for Use" section (Page 2 of the original document) states: "Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas)."
However, no specific performance metrics like sensitivity, specificity, accuracy, precision, or recovery are mentioned, nor is there any description of a study conducted to demonstrate these. Therefore, I cannot extract the requested information regarding acceptance criteria or a study from this document.
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(52 days)
JAS Diagnostics, Inc.
Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers.
Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
This Reagent is intended for the in vitro quantitative determination of creatine kinase in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the JAS Creatine Kinase (CK-NAC) Liquid Reagent:
Important Note: The provided document is a 510(k) summary for a medical device (a laboratory reagent), not a typical AI/ML device submission. Therefore, many of the requested categories like "multi-reader multi-case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only without human-in-the-loop performance)" are not applicable as this is not an AI-powered diagnostic device. The evaluation of this device focuses on its chemical performance and equivalence to existing reagents, not the performance of an algorithm.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Identical to predicate devices. | "The JAS Creatine Kinase (CK-NAC) Liquid Reagent's intended use is identical to predicate Devices." |
| Performance | "Acceptable result comparisons" with predicate devices. | "Correlation studies on human serum demonstrated acceptable result comparisons between these methods" |
| and | ||
| "it's performance acceptable on the automated chemistry analyzers tested." | ||
| Normal Ranges | Similar normal ranges to predicate devices. | "which all use similar normal ranges." |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "correlation studies on human serum" but does not provide a specific number of samples or subjects.
- Data Provenance: "human serum." The country of origin is not specified, but given the submitter's address in Miami, Florida, USA, it is likely from the United States. The studies appear to be retrospective or prospective clinical validation studies comparing the new reagent's performance against predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a chemical reagent, "ground truth" is typically established by the reference method or comparison to established, legally marketed predicate devices, not by expert interpretation in the way it would be for an image-based AI diagnostic. The comparison is against established laboratory testing methods.
-
Adjudication method for the test set:
- Not Applicable. As this is a chemical reagent, there's no "adjudication" in the sense of resolving disagreements between human readers or experts. The comparison is quantitative data obtained from automated chemistry analyzers.
-
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:
- No. This is a chemical reagent, not an AI-powered diagnostic device, so an MRMC study is not relevant or applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a lab reagent; there is no "algorithm" in the sense of AI. Its performance is measured as a component of an in vitro diagnostic test system.
-
The type of ground truth used:
- Reference Method/Comparative Performance: The ground truth for evaluating this reagent's performance is established by comparing its results to those obtained using legally marketed predicate devices (Roche Diagnostics CK NAC Reagent and Pointe Scientific Creatine Kinase (CK) Reagent) on automated chemistry analyzers. The aim is to demonstrate "acceptable result comparisons" and "similar normal ranges."
-
The sample size for the training set:
- Not Applicable. This is a chemical reagent; there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML models.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
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(44 days)
JAS Diagnostics, Inc.
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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(45 days)
JAS Diagnostics, Inc.
Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Carbon Dioxide Liquid Reagent. This document approves the device but does not contain the acceptance criteria or the study details that prove the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text. The text only confirms the device's classification and allows its marketing based on substantial equivalence to a predicate device, but it does not detail the performance study findings or acceptance criteria.
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