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Intended for the In Vitro, quantitative determination of Glucose in human serum, plasma urine. This "Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis andtreatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma". CFR862.1345

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This document is a 510(k) clearance letter from the FDA for a glucose test system. It does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The information provided is a regulatory approval, confirming that the device is substantially equivalent to a predicate device already on the market. It doesn't include performance metrics, study designs, or expert qualifications as requested in the prompt.

Therefore, I cannot answer the specific questions about acceptance criteria and study details based on the provided text.

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Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers.

"Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases." CFR 862.1030

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This document is a 510(k) clearance letter from the FDA for a medical device called "AST (GPT) Liquid Stable 2 Vial Reagent Incorporating DST." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter is primarily concerned with establishing substantial equivalence to a predicate device and discussing regulatory compliance.

Therefore, I cannot provide the requested information based on the given text. The text does not detail:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or study type (retrospective/prospective) for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results of a standalone algorithm-only performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for a training set.
9. How ground truth for a training set was established.

The letter explicitly states the device's indications for use: "Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers." It also references the use of Alanine aminotransferase (ALT/SGPT) measurements in the diagnosis and treatment of certain types of liver and heart diseases, as per CFR 862.1030. However, it does not provide performance metrics or study details to support these uses.

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Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers. "Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100

AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT

This document is an FDA 510(k) clearance letter for a medical device (AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST). It is a regulatory approval document and does not contain the information requested in your prompt regarding acceptance criteria, study details, or AI performance metrics.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself beyond its intended use.
2. Sample sizes used for the test set and the data provenance: No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
4. Adjudication method for the test set: No study details are provided.
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 device is a diagnostic reagent, not an AI system or imaging device requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used: No study details are provided.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

What the document does state about the device:

• Device Name: AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST
• Indications for Use: Intended for the in vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers.
• Purpose of AST (GOT) measurements (from CFR 862.1100): Used in the diagnosis and treatment of certain types of liver and heart disease.
• Regulatory Classification: Class II
• Determination: Substantially equivalent to devices marketed prior to May 28, 1976.

To answer your prompt, you would need a clinical study report or a 510(k) summary document that typically accompanies this clearance letter, which would describe the performance characteristics and testing conducted for the device.

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Intended for the the In Vitro, quantitative determination of ALT (L-Alanine;2-Oxoglutarate Aminotransferase EC2.6.1.2) in human serum on the Cobas MIRA® clinical chemistry system. This alanine aminotransferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine aminotransferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitus and cirrhosis) and heart diseases. CFR 862.1030

Intended for the the In Vitro, quantitative determination of KAMYLASE (1,4-%- D glucan glucanohydrolase EC3.2.1.1) in human serum and urine on the Cobas MIRA ® clinical chemistry system. This Amylase test system is a device intended to measure the activity of the enzyme Amylase in serum and urine . Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) CFR 862.1070

Intended for the the In Vitro, quantitative determination of AST (Aspartate aminotransferase EC2.6.1.1) in human serum on the Cobas MIRA ® clinical chemistry system. This "aspartate aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liverand heart disease." CFR 862.1100

Intended for the the In Vitro, quantitative determination of Direct Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Direct Bilirubin test system is a device intended to measure the levels of bilirubin (direct) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110

Intended for the the In Vitro, quantitative determination of Total Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Total Bilirubin test system is a device intended to measure the levels of bilirubin (Total) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110

Intended for the the In Vitro, quantitative determination of Calcium in human serum or urine on the Cobas MIRA ® clinical chemistry system. This "Calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms" CFR 862.1145

Intended for the the In Vitro, quantitative determination of Total CO2 in human serum on the Cobas MIRA ® clinical chemistry system. This " bicarbonatel carbon dioxide test system is a device intended to measure the total bicarbonate/carbon dioxide plasma, serum and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid base balance. " CFR 862.1160

Intended for the the In Vitro, quantitative determination of Chloride in human serum on the Cobas MIRA ® clinical chemistry system. This " Chloride test system is a device intended to measure the Chloride in plasma, serum, sweat and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. " CFR 862.1170

Intended for the the In Vitro, quantitative determination of Cholesterol in human serum on the Cobas MIRA ® clinical chemistry system. This " Cholesterol test system is a device intended to measure the Cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. " CFR 862.1175

Intended for the In Vitro, quantitative determination of Creatinine in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Creatinine test system is a device intended to measure the Creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases,in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. " CFR 862.1225

Intended for the the In Vitro, quantitative determination of Glucose in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Glucose test system is a device intended to measure the Glucose levels in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus,neonatal hypoglycemia , idiopathic hypoglycemia and pancreatic islet cell carcinoma. " CFR 862.1360

Intended for the the In Vitro, quantitative determination of Iron in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron (non-heme) test system is a device intended to measure Iron (non-heme)in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia , hemochromatosis ( a disease associated with widespread deposit in the tissues of two iron containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin) and chronic renal disease. " CFR 862.1410

Intended for the In Vitro, quantitative determination of Magnesium in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnasemia (abnormally high levels of magnesium). " CFR 862.1495

Intended for the the In Vitro, quantitative determination of Inorganic Phosphorus in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases , and vitamin D imbalance. " CFR 862.1580

Intended for the the In Vitro, quantitative determination of Total Protein in human serum on the Cobas MIRA ® clinical chemistry system. This " Total Protein test system is a device intended to measure Total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as other metabolic or nutritional disorders " CFR 862. 1635

Intended for the the In Vitro, quantitative determination of Triglycerides in human serum on the Cobas MIRA ® clinical chemistry system. This " Triglyceride test system is a device intended to measure Triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. " CFR 862.1705

Intended for the the In Vitro, quantitative determination of Urea Nitrogen in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " urea nitrogen test system is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in whole blood, serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. " CFR 862.1770

Intended for the the In Vitro, quantitative determination of Unbound Iron-Binding Capacity (UIBC) in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron-binding capacity test system is a device intended to measure Iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. " CFR 862.1415

Intended for the the In Vitro, quantitative determination of Uric Acid in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Uric Acid test system is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. " CFR 862.1775

Not Found

The provided documents are Indications for Use (IFU) statements and an FDA 510(k) clearance letter for the TRACE Reagent Line for the Cobas MIRA. These documents state the intended use and regulatory classification of the device but do not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The documents merely confirm that the TRACE Reagent Line for the Cobas MIRA is cleared for marketing as substantially equivalent to existing devices for the in vitro quantitative determination of various analytes (ALT, Amylase, AST, Direct Bilirubin, Total Bilirubin, Calcium, Total CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Inorganic Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Unbound Iron-Binding Capacity, and Uric Acid) on the Cobas MIRA clinical chemistry system.

To answer your request, detailed performance study reports, often found in the 510(k) submission itself (which is typically not publicly available in its entirety without a FOIA request), or in peer-reviewed publications, would be necessary.

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Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems.

Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome. " CFR 862.1065

Ammonia-Incorporating Dynamic Stabilization Technology (DST)

The provided text is a 510(k) clearance letter from the FDA for the device "Ammonia-Incorporating Dynamic Stabilization Technology (DST)". It outlines that the device is intended for "the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems." and that "Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome."

However, this document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, or ground truth establishment. It is a regulatory clearance document, not a clinical study report. Therefore, I cannot generate the requested information based on the provided text.

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Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis.

"This Amylase test system is a device intended to measure the activity of the enzyme amylase in serum, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)". , CFR 862.1070

TRACE Amylase - DST Reagent

The provided documents are a 510(k) premarket notification letter from the FDA for a device called "TRACE Amylase - DST Reagent." This is not a study report or clinical trial document for a medical AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them.

The 510(k) letter confirms that the device is "substantially equivalent" to predicate devices already on the market, meaning it has similar indications for use and technological characteristics. It does not elaborate on specific performance data or studies beyond stating that a review was conducted.

To answer your questions, I would need a document that describes a clinical or analytical study performed to evaluate the performance of an AI/ML medical device, including acceptance criteria and results.

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Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis.

"This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770

TRACE Urea (Urea Nitrogen) - DST Reagent

This document is a 510(k) premarket notification approval letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot extract the requested information from this document.

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Intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis.

"This Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs", CFR 862.1775

TRACE !!!ric Acid - DST Reagent

The provided document is a 510(k) clearance letter from the FDA to TRACE America, Inc. for their Uric Acid - DST Reagent. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, study details, or performance data as requested in your prompt.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical trial report, or the 510(k) submission itself, which would typically include such details.

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Ask a specific question about this device