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The EasyRA TBIL reagent is intended for the quantitative measurement of Total Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only.

The EasyRA DBIL reagent is intended for the quantitative measurement of Direct Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only.

The EasyRA CK reagent is intended for the quantitative determination of Creatine Kinase (CK) in human serum and plasma, using the MEDICA "EasyRA Chemistry analyzer" in clinical laboratories. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only.

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This is a 510(k) premarket notification for in-vitro diagnostic reagents, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and ground truth for an AI/ML device is not applicable here.

The document discusses the substantial equivalence of the EasyRA Total Bilirubin Reagent, EasyRA Direct Bilirubin Reagent, and EasyRA Creatinine Kinase Reagent to legally marketed predicate devices. The review is focused on the regulatory classification and general controls provisions for these diagnostic reagents.

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The EasyRA HbA1c Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood using the EasyRA clinical chemistry analyzer. HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
The EasyCAL HbA1c calibrator is used for calibrating the HbA1c on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA HbA1c Reagent. The HbA1c calibrator is used to establish points of reference that are used in the determination of values in the measurement of HbA1c in human whole blood.
The EasyQC HbA1c QC Materials are intended to use as quality control material for the HbA1c immunoturbidimetric assay, using EasyRA HbA1c Reagent and EasyCAL HbA1c calibrator on the EasyRA clinical chemistry analyzer.

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This is a 510(k) clearance letter for the EasyRA HbA1c Reagent Kit, HbA1c Calibrator Kit, and HbA1c QC materials. The document indicates that these are in-vitro diagnostic devices intended for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood using the EasyRA clinical chemistry analyzer. HbA1c measurements are used for monitoring long-term blood glucose control in diabetic patients.

However, the provided document does not contain any information regarding acceptance criteria, study details (like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment) or reported device performance. The document is solely a formal letter from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided.

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The EasyRA PPX reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene (PPX) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point of the assay is 300ng/ml, and provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory method. The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GC/MS or LC/MS and to allow laboratories to establish effective quality control procedures for the PPX assay.

Medica's Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent on the EasyRA clinical chemistry analyzer.

Medica's Propoxyphene (PPX) QC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.

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This document is a 510(k) premarket notification decision letter from the FDA for in vitro diagnostic devices (IVDs) related to Propoxyphene (PPX) testing. It does not contain information about acceptance criteria or a study proving device performance as requested.

The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's performance is considered similar enough to existing devices, and a separate study demonstrating new acceptance criteria or performance against such criteria is not typically required in a 510(k) for substantial equivalence.

Therefore, I cannot provide the requested information from the given text because it is not present.

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The EasyRA EtOH reagent is intended for the quantitative measurement of Alcohol (EtOH) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning.

The EasyCal Ethanol Calibrator is intended for in-vitro diagnostic use for the calibration of the ethyl alcohol assay on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.

The EasyQC Ethanol quality control material is intended for in-vitro diagnostic use for the validation of the ethyl alcohol assay, which is used on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.

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The provided text is a 510(k) premarket notification letter from the FDA to Medica Corporation regarding their Easy RA Ethyl Alcohol Reagent, Calibrator, and QC Material. It details the regulatory approval of the devices for "quantitative measurement of Alcohol (EtOH) in human urine" and states that "Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning."

However, this document does not contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for these devices. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

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The EasyLyte Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na+), Potassium(K+), and ionized Calcium(Ca++) with pH correction in clinical laboratories by trained technicians.

Sodium test: The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large anounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's discase (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium test: The potassium (K+) assay is intended to measure potassium in serum, plasma, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Calcium-ionized test: The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. fonized 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). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium.

pH test: The sample pH assay is intended to measure the pH of the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pH other than 7.40 units,

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The provided document K112788 is a 510(k) clearance letter for the Medica Corp. EasyLyte Na/K/Ca/pH Analyzer. It does not contain detailed information about acceptance criteria or the specific study details proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria in the format requested.

Therefore, many of the requested points cannot be answered from the provided text.

However, based on the information provided, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

This information is not present in the provided document. The document is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not present in the provided document.

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):

This information is not present in the provided document. The EasyLyte Na/K/Ca/pH Analyzer is an in-vitro diagnostic device, so the ground truth would typically be established by a reference method or laboratory.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not present in the provided document.

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 is not applicable as the EasyLyte Na/K/Ca/pH Analyzer is an in-vitro diagnostic device for measuring electrolytes and pH, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable in the context of an AI-driven standalone algorithm. The device itself is a standalone analyzer for in-vitro diagnostic testing, meaning its performance is evaluated based on its own measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not explicitly stated in the provided document. For an in-vitro diagnostic device like this, the ground truth would typically be established by a well-characterized reference measurement method or a validated laboratory standard.

8. The sample size for the training set:

This information is not present in the provided document. The device is not described as a machine learning/AI model that would have a "training set" in the conventional sense. Its development would involve calibration and validation data, but not a training set in the AI context.

9. How the ground truth for the training set was established:

This information is not present in the provided document due to the nature of the device (see point 8).

In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical study information required to answer most of your questions about acceptance criteria and study design. Such details would typically be found in the 510(k) submission itself or accompanying technical documentation, which is not part of this public clearance letter.

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The EasyRA µALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases.

The EasyRA micro-albumin (µALB) calibrator facilitates measurements of µALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's µALB reagent. The µALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of µALB in human urine.

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The provided text is a 510(k) summary for a medical device called "EasyRA micro-albumin (uALB) Reagent and EasyRA microalbumin (uALB) Calibrator." It describes the intended use of the device and confirms its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory clearance letter.

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The EasyRA Alkaline phosphatase (ALP) reagent is intended for the quantitative determination of alkaline phosphatase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. For in vitro diagnostic use only.

The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of alkaline phosphatase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. For in vitro diagnostic use only.

The EasyRA Amylase (AMY) reagent is intended for the quantitative determination of amylase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. a-Amylase in serum/plasma is used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format you requested. The document is a 510(k) clearance letter from the FDA for several "EasyRA" reagents. It focuses on the substantial equivalence determination and the indications for use of these diagnostic reagents.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, training sets, or how ground truth was established for these.
• Information on the number or qualifications of experts used for ground truth, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).

The document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based on the provided input.

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EasyRA BUN Reagent: The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the "EasyRA chemistry analyzer". Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. EasyRA CREA Reagent: The EasyRA Creatinine (CREA) Reagent is for the measurement of Creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.

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This is a 510(k) premarket notification for in vitro diagnostic reagents, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study design for AI performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document. The document primarily focuses on establishing substantial equivalence for the EasyRA BUN Reagent and EasyRA CREA Reagent to predicate devices.

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The EasyRA albumin reagent is intended for the quantitative determination of Albumin (ALB) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only.

The EasyRA total calcium reagent is intended for the quantitative measurement of Total Calcium (Ca) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety if bone diseases, chronic renal disease and tetany. For in vitro diagnostic use only.

The EasyRA magnesium reagent is intended for the quantitative measurement of Magnesium (Mg) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.

This reagent is intended for the quantitative measurement of Inorganic Phosphorous (PHOS) in human serum and plasma. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance.

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This document is a 510(k) clearance letter for in vitro diagnostic reagents, not a study describing the performance of an AI-powered medical device. As such, most of the requested information (acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

The document discusses the regulatory clearance of "EasyRA Albumin Reagent, EasyRA Calcium Reagent, Easy RA Magnesium Reagent, Easy RA Inorganic Phosphorus Reagent" for use with the MEDICA "EasyRA Chemistry Analyzer" for quantitative determination of various substances in human serum and plasma.

Therefore, I cannot provide a table of acceptance criteria, device performance, study details, or information related to AI performance from this document.

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The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. For in vitro diagnostic use only.

The EasyRA potassium test is intended for the quantitative determination of potassium ions (K+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only.

The EasyRA chloride test is intended for the quantitative determination of chloride ions (Cl) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only.

The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only.

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This document is a 510(k) premarket notification decision letter from the FDA for in vitro diagnostic devices (EasyRA Sodium, Potassium, Chloride, and Carbon Dioxide assays). It confirms substantial equivalence to predicate devices. However, it does not contain a study that proves the device meets acceptance criteria.

The letter itself states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has determined the new device is as safe and effective as a legally marketed predicate device, primarily based on the information provided by the applicant in their 510(k) submission. The letter does not include the details of the studies or acceptance criteria that were used within that submission.

Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need to review the actual 510(k) submission document itself, which is not provided here.

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