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The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances.

Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Calcium (Ca++) (ionized) 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).

Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor, used in the calculation of the patient sample.

The analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯.

The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.

Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days.

The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC.

The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.

The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material information. Details are provided in the operator's Manual.

To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.

Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.

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The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.

Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.

The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor used in the calculation of the patient sample. The EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual. The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation. The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. Medica's EasyQC materials are specifically formulated for the EasyStat 300. The EasyStat 300 may be equipped with a Medica provided barcode scanner via a USB port to automatically enter patient sample and EasyQC material info. To maintain the performance of the analyzer Medica provides a cleaning solution and a troubleshooting kit.

Here's a breakdown of the acceptance criteria and the study that proves the EasyStat 300 device meets these criteria, based on the provided FDA 510(k) summary.

Key Findings from the Document:

• Device: EasyStat 300 Blood Gas Analyzer
• Purpose: Measures pO2, pCO2, and pH in whole blood.
• Comparison: Substantially equivalent to its predicate device, the EasyStat Blood Gas Analyzer (K021515).
• Studies Conducted: Precision (Repeatability, Reproducibility), Linearity, Method Comparison, Sensitivity, and Selectivity (Interference).
• Ground Truth for Analytical Studies: Primarily based on pre-assayed whole blood samples, aqueous QC materials, and tonometered whole blood, with comparisons against results from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table labeled "Acceptance Criteria," but rather presents "Performance Specs" within the precision studies and "Status" (PASS) for linearity and method comparison, indicating adherence to pre-defined criteria. The interference study uses a "Conclusion" column based on a predefined percentage change. Based on the data provided, the acceptance criteria are inferred from the "Performance Specs" headers and the overall "PASS" status for each test.

• System 1 PO2 Level 1: 1.39 SD (vs 2.5 SD)
• System 1 PCO2 Level 1: 0.9 CV (vs 5.0% CV)
• System 1 pH Level 1: 0.002 SD (vs 0.020 SD)

Aqueous Controls (Capillary Mode): All results "within specification." Examples:

• Unit 1 PO2 Level 1: 2.70 SD (vs 3 SD)
• Unit 1 PCO2 Level 1: 1.5 CV (vs 5.0% CV)
• Unit 1 pH Level 1: 0.004 SD (vs 0.020 SD) |
  | Reproducibility | pO2: Level 1: 2.5mmHg; Level 2: 2.5mmHg; Level 3: 3.0% CV | 5-day w. Blood Study (Syringe Mode): All results "within specification." Examples:
• PO2 Level 1: 0.6 SD (vs 2.5mmHg)
• PCO2 Level 1: 0.5 SD (vs 2.0% CV, implied from table structure)
• pH Level 1: 0.007 SD (vs 0.015 units)

5-day w. Blood Study (Capillary Mode): All results "within specification." Examples:

• PO2 Level 1: 0.9 SD (vs 2.4mmHg)
• PCO2 Level 1: 2.5 CV (vs 4.0% CV)
• pH Level 1: 0.008 SD (vs 0.015 units) |
  | Linearity | "met all device specifications" (implied criteria typically high R^2 values, slope ~1) | Data shown (e.g., for ES300-P7):
• PO2 (Syringe): R² 0.999, Slope 1.016 (PASS)
• PCO2 (Syringe): R² 0.999, Slope 1.066 (PASS)
• pH (Syringe): R² 0.996, Slope 1.008 (PASS)
  Conclusion: "all analytes... are linear within the advertised reportable range." |
  | Method Comparison | "linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications." (implied) | Exemplified by PO2 Syringe Mode:
• n=272, Slope=1.001, R²=0.999
• Predicted Bias for PO2 (30.0, 45.0, 60.0): All PASS ("within specifications," typically close to 0 bias and CI within allowable error).
  Conclusion: "all analytes... are favorably correlated to the predicate/reference device... within specifications." |
  | Sensitivity | LoQ

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The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen: Amphetamines, Barbiturates (Butalbital), Benzodiazepines (Oxazepam), Buprenorphine, Cocaine, MDMA (Methylenedioxymethamphetamine), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Tricyclic Antidepressants. The test is intended for over-the-counter use.

Rapid TOX Cup II is a drug test that can detect 1 to 13 drugs in human urine. Rapid TOX Cup II is collection cup with a temperature strip attached. It contains an insert with one or more test strips in the insert. Each test strip can test for up to 4 different drugs. The test is for over-the-counter or professional use. Rapid TOX CUP II is a first step in a 2-step process. The test provides information about the presence of certain drugs in urine. The second step in the process is more specific testing by a laboratory.

Here is a description of the acceptance criteria and the study proving the device meets them, based on the provided text:

This document describes the performance of the Rapid TOX Cup II, a urine drug screening device.

1. Table of Acceptance Criteria and Reported Device Performance

The device is an in vitro diagnostic test designed to qualitatively detect various drugs of abuse in human urine. The acceptance criteria are implicit in the "consumer study" results, which show the device's accuracy at different drug concentrations relative to predefined cutoffs. The "acceptance criteria" are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%), but rather demonstrated through the concordance of the device's positive and negative results with expected outcomes based on the spiked concentrations.

Below is a summary table demonstrating the device's performance for each tested drug across different concentrations, as reported in the consumer study. The "Rapid TOX Cup II Result" indicates how the device interpreted the prepared samples.

Table 1: Rapid TOX Cup II Reported Device Performance (Consumer Study Results)

Interpretation of Performance:

The results indicate that:

• For samples with "No Drug Present" or "Less than 50% of the cutoff concentration," the device predominantly yielded NEGATIVE results, demonstrating high specificity below the cutoff.
• For samples "Between the cutoff and 50% above the cutoff concentration" and "Greater than 50% above the cutoff concentration," the device consistently yielded POSITIVE results, demonstrating high sensitivity at or above the cutoff.
• For samples "Between 50% below the cutoff and the cutoff concentration," there was a mix of positive and negative results, which is expected for lateral flow assays as performance at these "near cutoff" concentrations can vary. However, the majority of these samples still yielded NEGATIVE results, indicating appropriate cutoff performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The sample sizes vary per drug type and concentration level. For each drug and cutoff level, there were:
  • Between 80 and 960 samples for "No Drug Present" (Negative).
  • 20 samples for "Less than 50% of the cutoff."
  • 40 samples for "Between 50% below the cutoff and the cutoff."
  • 40 samples for "Between the cutoff and 50% above the cutoff."
  • 20 samples for "Greater than 50% above the cutoff."
  • This totals approximately 140 to 1080 samples per drug/cutoff combination for the consumer study. The document lists 17 unique drug/cutoff combinations, meaning the total number of individual tests performed in the consumer study would be significant.
• Data Provenance: The data was generated through a prospective consumer study. The document does not specify the country of origin for the data or the participants, but given the FDA submission, it is likely that the study was conducted in the United States or in accordance with US regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Experts and Qualifications: The document does not mention the use of human experts (e.g., radiologists) to establish ground truth for this medical device.
• Ground Truth Establishment: The ground truth for the test set was established by preparing samples with known concentrations of drug analytes. These are "spiked" samples with precise, known quantities of the drugs or their metabolites, relative to the device's specified cutoff levels. This is a common and robust method for establishing ground truth in in vitro diagnostic studies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the ground truth was established by known concentrations in prepared samples, there was no need for adjudication among human readers or experts. The device's output (positive/negative) was compared directly to the known concentration of the spiked sample.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers are involved in the interpretation process. The Rapid TOX Cup II is an in vitro diagnostic device that provides a direct "positive" or "negative" qualitative result.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted. The study's purpose was to show the device's performance when interpreted by "untrained consumers" in an OTC setting, comparing their interpretation of the device's visual readout to the true spiked concentrations, rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Performance: Not explicitly separated as "algorithm only." The device itself (the Rapid TOX Cup II) is the "algorithm" in this context (a lateral flow immunoassay). The study evaluated how well untrained consumers could generate a result and interpret it from the physical device. Therefore, the reported performance is effectively the "standalone performance" of the device as it would be used by an end-user, including the user's interpretation of the visual output. The device is not an AI algorithm in the traditional sense that operates independently of a user interface or human input for interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was known, prepared concentrations of drug analytes in urine samples. This is a form of "laboratory-controlled" or "spiked sample" ground truth, which is highly precise and accurate for evaluating the analytical performance of in vitro diagnostic tests. While clinical outcomes or expert consensus might be used for other types of devices, for a rapid drug screen, known concentrations are the gold standard for analytical validation.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a "training set" in the context of machine learning or AI algorithm development. The Rapid TOX Cup II is a chemical immunoassay, not an AI or machine learning model. Therefore, the concept of a "training set" and "test set" in the AI sense does not apply to the device's development or validation in this document. The samples described were used for a performance validation study (akin to a test set in the analytical validation context).

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an immunoassay device. The ground truth for the validation study (the "consumer study") was established by precisely preparing urine samples with known concentrations of drug analytes, as detailed in point 7.

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The EasyLyte Na/K/C/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and lonized Calcium (Ca++) without pH correction.

The ionized calcium test on the EasyLyte Na/K/C//Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany finternittent muscular contractions or spasms).

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The provided text is a 510(k) premarket notification letter from the FDA to MEDICA CORPORATION for their EasyLyte Na/K/Cl/Ca Analyzer. This document primarily focuses on the regulatory aspects of the device, stating that the FDA has determined it is "substantially equivalent" to legally marketed predicate devices.

However, the letter does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the device's 510(k) submission itself, which is a much larger and more technical document than the FDA's regulatory response letter.

Therefore,Based on the provided document, I cannot accurately describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.

To answer your questions, I would need access to the actual 510(k) submission for K152327, which contains the detailed technical and clinical performance data.

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The EasyRA Creatine Kinase-MB (CK-MB) Reagent is intended for the quantitative determination of CK-MB activity in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements of CK-MB activity 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. For prescription use only.

Medica's EasyRA C-Reactive Protein (CRP) Reagent is intended for use in the quantitative in-vitro diagnostic determination of C-reactive protein in human serum or plasma using the EasyRA clinical chemistry analyzer. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in-vitro diagnostic use only. For prescription use only.

The EasyCAL C-Reactive Protein (CRP) Calibrator Kit is used for calibrating the CRP assay on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA CRP Reagent. The CRP calibrators are used to establish points of reference that are used in the determination of values in the measurement of CRP in human serum and plasma. For in-vitro diagnostic use only. For prescription use only.

The EasyQC C-Reactive Protein (CRP) Quality Control Materials are intended for use as quality control material for the CRP turbidimetric assay, using the EasyRA CRP Reagent and calibrator kit on the EasyRA clinical chemistry analyzer. For in-vitro diagnostic use only. For prescription use only.

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This document is a letter from the FDA regarding the 510(k) premarket notification for several diagnostic reagents and related calibrator/control materials. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not performance studies.

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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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The provided document is an FDA 510(k) clearance letter for the EasyRA Creatinine Reagent. It states that the device is substantially equivalent to a predicate device for measuring creatinine in serum and plasma.

However, this document does not contain the specific information required to answer your request about acceptance criteria and study details. The 510(k) clearance letter itself is a summary of the FDA's decision, not the full submission that would detail the performance studies and acceptance criteria.

To answer your questions, one would need access to the actual 510(k) premarket notification submission for K123586, which would include the performance data and the study design.

Therefore, I cannot provide the requested table and study details based solely on the provided text. The document confirms the device's indications for use: "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." but does not elaborate on the performance characteristics or the studies conducted to establish substantial equivalence.

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QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.

The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.

Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.

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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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