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CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

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This document is an FDA 510(k) clearance letter for three BioSystems S.A. reagents: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, and UREA/BUN-UV. As such, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML medical device.

The information typically provided in a 510(k) summary for in vitro diagnostic (IVD) reagents like these focuses on analytical performance characteristics (e.g., linearity, precision, accuracy, interference, stability) and correlation with a predicate device, rather than the AI/ML-specific criteria requested in the prompt.

Therefore, it is impossible to answer the questions based on the provided text. The document is about chemical reagents for laboratory testing, not an AI-powered diagnostic device.

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I am sorry, but the provided text is a standard FDA clearance letter and does not contain information about the acceptance criteria, study details, or performance of the "Transferrin" device mentioned. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical or clinical study data.

To answer your request, I would need a document that describes the actual performance study and its results.

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alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent institus of in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic c-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronin pancreatitis. This reagentis for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, herrytological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for nuse in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

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This 510(k) summary provides information about the substantial equivalence of several Biosystems S.A. reagents (alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL) to legally marketed predicate devices. It states that the devices are intended for in vitro diagnostic use in the clinical laboratory for measuring specific analyte concentrations in human serum, plasma, or urine, which are useful as aids in the diagnosis and treatment of certain medical conditions. However, the document does not contain any data, studies, or information regarding acceptance criteria or device performance statistics. It is a regulatory clearance letter, not a performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the validation and performance characteristics of these reagent systems.

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BA400: The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood. This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity.

ALBUMIN: Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

ALKALINE PHOSPHATASE (ALP) - AMP: Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE-HEXOKINASE: Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

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This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic reagents and an analyzer. It only provides information about the intended use of the devices and their regulatory classification. It does not contain any data, studies, acceptance criteria, or performance results for the devices mentioned (ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE reagents, or the BA400 analyzer).

Therefore, I cannot provide the requested information in the requested format because the input document does not contain it.

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