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The Acetaminophen assay is used for the quantitative determinophen in human serum or plasma on the ARCHITECT c Systems.

The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.

The Acetaminophen assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in human serum and plasma. The assay consists two working reagents, an enzyme reagent and a color reagent.

The enzyme reagent contains aryl acylamidase, which cleaves the amide bond of acetaminophen, forming p-aminophenol which then reacts with the 2,5-dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 660 nm which is directly proportional to the acetaminophen concentration in the sample.

Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers in conjunction with a calibrator (510(k) exempt) which is provided separately.

The provided text describes a 510(k) premarket notification for an Acetaminophen assay (K202644). The document details various performance studies conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

The SEKURE Acetaminophen L3K assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in serum, lithium heparin plasma and sodium heparin plasma. The assay consists two working reagents, an enzyme reagent and a color reagent. The enzyme reagent contains acyl amidohydrolase, which cleaves the amide bond of the acetaminophen, forming p-aminophenol which then reacts with the 2,5- dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 605 nm which is directly proportional to the acetaminophen concentration in the sample. Testing is performed on open system clinical chemistry analyzers, such as the Hitachi 717 (K872494) in conjunction with a calibrator (510(k) exempt) which is included and controls which are provided separately.

The provided document is a 510(k) Pre-market Notification for a medical device called the "SEKURE Acetaminophen L3K Assay." This document describes the analytical studies conducted to demonstrate the device's performance and substantial equivalence to a predicate device, rather than a study involving human readers or AI assistance in image interpretation. Therefore, many of the requested points related to AI, human reader performance, expert consensus, and MRMC studies are not applicable to this type of device submission.

Here's an analysis based on the available information:

Device Type: In vitro diagnostic device (IVD) for quantitative measurement of acetaminophen in biological samples.

Focus of the Document: Analytical performance studies (precision, analytical sensitivity, linearity, interference, method comparison, matrix comparison) to demonstrate the assay's accuracy and reliability.

Information NOT Applicable to this Document Type:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Data provenance is typically not detailed for IVD analytical studies in this manner; samples are clinical specimens or prepared materials.
• 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) - Ground truth for IVDs is established by reference methods or gravimetric preparation, not expert review of images.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for IVD analytical studies.
• 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 is not an AI-assisted diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable; this is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Ground truth is established by reference methods, gravimetric preparation, or theoretical values.
• The sample size for the training set - Not applicable; this device does not use an AI training set.
• How the ground truth for the training set was established - Not applicable.

Acceptance Criteria and Reported Device Performance

The device is an in vitro diagnostic assay, and its performance is evaluated through various analytical studies. The acceptance criteria are therefore analytical performance specifications, not clinical outcomes directly.

Here's a table summarizing the acceptance criteria and a selection of reported performance data from the document:

Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria

The study that proves the device meets the acceptance criteria is a series of Non-Clinical Performance Data studies, as detailed in the "510(k) Summary" document. These are analytical studies, typically following CLSI (Clinical and Laboratory Standards Institute) guidelines, to characterize the performance of the in vitro diagnostic assay.

1. Sample Sized Used for the Test Set and Data Provenance:

• Precision: 80 measurements per sample/control per lot (assayed in duplicate twice a day for 20 days). This included two unaltered patient serum samples, two spiked patient serum samples, and three levels of controls. Data is likely from laboratory samples, not specified by country.
• Analytical Sensitivity (LoB/LoD): 60 measurements per lot (five blank samples and five low concentration samples in quadruplicate over three operating days).
• Analytical Sensitivity (LoQ): 40 replicates per low concentration sample per lot (five low concentration samples tested in 40 replicates over five runs across three operating days).
• Linearity/Assay Reportable Range: 4 replicates per sample per lot (nine internally prepared samples across the measuring range).
• Analytical Specificity (Interference): 5 replicates per interferent concentration per acetaminophen concentration (tested at 3-4 acetaminophen concentrations).
• Method Comparison: 105 patient specimens, tested in duplicate, over seven operating days. Samples were distributed evenly throughout the assay range.
• Matrix Comparison: 40 matched sets of patient specimens.

Data Provenance: The document does not explicitly state the country of origin for patient samples or whether they were retrospective or prospective. However, for analytical performance, samples are typically collected from a pool of patient samples or are internally prepared clinical matrix materials.

2. Number of Experts and Qualifications:

• Not applicable. This device is an analytical chemistry assay, not one that relies on human experts for interpretation or ground truth establishment. The performance is assessed against quantitative analytical standards and a predicate device.

3. Adjudication Method:

• None. Not applicable for analytical performance studies of an IVD assay.

4. MRMC Comparative Effectiveness Study:

• No. Not applicable as this is not an imaging device or an AI-assisted diagnostic device.

5. Standalone Performance:

• Yes (in the context of an IVD). The performance data presented (e.g., precision, analytical sensitivity, linearity, interference) represent the standalone performance of the SEKURE Acetaminophen L3K Assay itself, without a "human-in-the-loop" in the artificial intelligence sense. The assay quantitatively measures acetaminophen concentration.

6. Type of Ground Truth Used:

• Reference Methods / Gravimetric Preparation / Theoretical Values / Predicate Device Comparison.
  • Precision: Relative to the mean of repeat measurements.
  • Analytical Sensitivity: Derived statistically from blank and low-level samples.
  • Linearity: Compared to theoretical concentrations of gravimetrically prepared standards.
  • Interference: Compared to control samples without interferent.
  • Method Comparison: Compared to measurements obtained using a legally marketed predicate device (SEKURE Acetaminophen L3K Assay, K081938). This is a common form of "ground truth" for demonstrating substantial equivalence for IVDs.
  • Matrix Comparison: Compared to serum samples (considered the reference matrix).

7. Sample Size for the Training Set:

• Not applicable. This device is an in vitro diagnostic assay, not an AI algorithm that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

• Not applicable. See above.

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The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers.

The Roche Diagnostics Acetaminophen assays under consideration in this submission are the same assays as were cleared on the COBAS Integra in K991598, Hitachi 917 in K013757 and cobas c501 in K060373 for the quantitative determination of toxic levels of Acetaminophen in human serum and plasma on automated clinical chemistry analyzers. The same reagents are used on all three systems. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently, the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically. The change in absorbance is directly proportional to the quantitative drug concentration in the sample.

The acceptance criteria for the Roche Acetaminophen assay are based on demonstrating substantial equivalence to previously cleared predicate devices: Roche COBAS Integra Acetaminophen assay (K991598), Roche/Hitachi Acetaminophen assay (K013757), and cobas c501 Acetaminophen assay (K060373). The study performed by Roche Diagnostics focused on validating the performance of the new Roche Acetaminophen assays on the cobas 8000 Modular Analyzer Series, specifically on the cobas c501 and Hitachi 917 platforms, and confirming similar performance on the COBAS Integra platform.

The study did not explicitly state "acceptance criteria" in terms of numerical thresholds for performance metrics. Instead, it demonstrated equivalence by comparing the analytical characteristics of the new assays with those of the predicate devices. The key performance aspects compared include:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

Important Note on Measuring Range and Sensitivity: While the new device's LoB is 1.2 µg/ml for all platforms, the "Measuring range" starts at 15 µg/ml. This is a key difference from the predicate devices which had measuring ranges starting at their respective LDLs (1.2 µg/ml or 0.7 µg/ml). The LoQ (Limit of Quantitation) of 15 µg/ml seems to define the lower end of the measuring range for the new device. Additionally, the new assays performed more extensive bilirubin interference testing (at 15, 30, and 50 µg/ml) compared to the predicates (only at 50 µg/ml).

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state the sample sizes used for the analytical performance studies (e.g., for LoB, LoD, LoQ, measuring range, specificity, or interference testing).
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to this type of submission. This is a 510(k) for an in vitro diagnostic (IVD) assay based on chemical/enzymatic reactions. The "ground truth" for an IVD assay's analytical performance (e.g., concentration of acetaminophen) is established through reference methods, certified reference materials, and robust analytical chemistry techniques, not through expert consensus on images or clinical outcomes.

4. Adjudication method for the test set:

• This information is not applicable as it pertains to expert reviews of data, which is not how analytical performance of IVD assays is typically established.

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, an MRMC comparative effectiveness study was not done. This is an IVD device, not an AI-powered diagnostic system that assists human readers.

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

• Yes, the performance described is the standalone performance of the analytical assay (the "algorithm" here is the chemical reaction and measurement system). There is no "human-in-the-loop" performance being evaluated in the context of this device's function.

7. The type of ground truth used:

• The "ground truth" for the analytical performance of this assay would be established using reference methods (e.g., gas chromatography-mass spectrometry (GC-MS) or high-performance liquid chromatography (HPLC) for acetaminophen quantification) and certified reference materials with known concentrations of acetaminophen. The document doesn't explicitly detail the reference methods used but implies the use of quantitative standards for calibration and evaluation.

8. The sample size for the training set:

• This information is not explicitly stated as it's an analytical assay and not a machine learning algorithm that typically requires a distinct "training set." The development of such assays involves extensive R&D, method optimization, and analytical validation which uses various samples and experiments, but these are not typically referred to as a "training set" in the context of AI/ML.

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

• As above, the concept of a "training set" with established ground truth in the AI/ML sense is not applicable here. The analytical accuracy and precision are established through internal validation studies using known concentrations of analytes and comparison to reference methods, not through human-adjudicated ground truth.

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For in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Such measurements are used in the detection of acetaminophen overdose.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the ADVIA® Chemistry Acetaminophen Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a medical imaging AI device submission would.

Medical device submissions for invitro diagnostic devices like this one focus on demonstrating substantial equivalence to a predicate device, and performance is typically evaluated through analytical validation studies (e.g., accuracy, precision, linearity, interference) rather than clinical studies with "test sets," "ground truth," or "expert readers" as you might find for an imaging AI.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device and regulatory submission.

Specifically, the information you requested would not typically be found in this type of document:

1. A table of acceptance criteria and the reported device performance: This document is the FDA's decision letter, not the submission itself which would contain such tables. Furthermore, for IVD devices, these criteria relate to analytical performance characteristics rather than diagnostic performance metrics like sensitivity/specificity derived from expert readings.
2. Sample size used for the test set and the data provenance: Not applicable in the context of this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a reagent for an automated chemistry analyzer, not an AI algorithm in the sense of imaging analysis.
7. The type of ground truth used: For an acetaminophen assay, "ground truth" would generally be established by highly accurate reference methods or known spiked concentrations, not expert consensus or pathology in this context.
8. The sample size for the training set: Not applicable as it's not an AI/machine learning model in the typical sense that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

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For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

Here's a breakdown of the acceptance criteria and study details for the Acetaminophen L3K® Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states "Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device" and focuses on the high correlation coefficients and favorable regression results as proof of this equivalence, rather than explicitly listing numerical thresholds for acceptance. The core of the acceptance criteria for a 510(k) often revolves around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

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

• Serum Test Set Sample Size: 100 samples
• Plasma Test Set Sample Size: 25 samples
• Data Provenance: Not explicitly stated regarding the country of origin. The submission is from Genzyme Diagnostics P.E.I. Inc. in Canada, so it's likely the data originated there or in a region where they conducted their studies. The data is retrospective as it involves comparing the new device's measurements against an existing "reference method" (presumably the predicate device or a clinical laboratory's established method).

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

• This information is not provided in the given document. For an in vitro diagnostic (IVD) like this, "ground truth" would typically be established by comparing the device's results to a recognized reference method or a method already validated for clinical use, rather than expert consensus on individual cases. The "reference method" is the de facto "ground truth" here.

4. Adjudication Method for the Test Set

• This information is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or endpoint determination requires consensus among multiple experts. For a quantitative assay, the comparison is directly numerical against a reference method.

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 was not done. The Acetaminophen L3K® Assay is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.

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

• Yes, this was a standalone performance study. The Acetaminophen L3K® Assay is a laboratory assay that produces quantitative results directly. Its performance was evaluated purely on its analytical capabilities (accuracy, correlation) when measuring acetaminophen in samples, without any human-in-the-loop interpretation beyond standard laboratory procedures and result reporting.

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

• The ground truth was established by a "similar acetaminophen method" referred to as the "reference method" in the serum comparison and the "This method (serum)" in the plasma comparison. This implies an existing, validated laboratory method. For IVDs, this is often a widely accepted and validated analytical method or the predicate device itself.

8. The sample size for the training set

• This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The studies described are validation (test) studies to demonstrate performance. The "training" for such an assay would be its initial development and optimization, which isn't typically detailed in a 510(k) summary for a chemical assay.

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

• This information is not applicable as there is no mention of a "training set" in the context of an AI/ML device. For the development of the assay, standard analytical chemistry principles, method development, and optimization techniques would have been employed to ensure accuracy, but this is distinct from establishing ground truth for machine learning.

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The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge 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.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge 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.

The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge 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.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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

The document states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the common confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

Acceptance Criteria and Study for Triage® TOX Drug Screen

This response details the acceptance criteria and the study proving the Triage® TOX Drug Screen meets these criteria, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary only explicitly reports the agreement for Acetaminophen/Paracetamol. For other drug classes, the summary states that "The analytical performance characteristics of the assay were equivalent to predicate methods," but does not provide specific agreement percentages or studies for each individual drug class in the provided text. The table above reflects the information available in the given document. The acceptance criterion for each drug class is its specified threshold concentration.

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

• Test Set Sample Size:
  • For Acetaminophen/Paracetamol: 102 specimens were used for the method comparison study.
  • Specifically, 20 of these specimens were within ±25% of the cutoff concentration.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The summary only mentions "specimens" without further details on their source.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The provided 510(k) summary does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• The provided 510(k) summary does not mention an adjudication method. For the Acetaminophen/Paracetamol study, the comparison was made directly against a reference method (GC/MS).

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated fluorescence immunoassay (point-of-care qualitative determination) and does not involve human readers interpreting images or data where AI assistance would typically be evaluated for reader improvement.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the Acetaminophen/Paracetamol assay. The summary describes a "method comparison of acetaminophen results with GC/MS" and reports an "overall agreement of 97.1%." This is the algorithm's (device's) performance without human-in-the-loop. The summary also states, "The analytical performance characteristics of the assay were equivalent to predicate methods," implying similar standalone performance evaluations for other drug classes, although specific data is not provided in this extract.

7. Type of Ground Truth Used

• For the Acetaminophen/Paracetamol assay, the ground truth was established using an alternate chemical method: Gas Chromatography/Mass Spectroscopy (GC/MS). For acetaminophen/paracetamol specifically, "A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method." The summary implies GC/MS as the common confirmatory method for other drug classes generally.

8. Sample Size for the Training Set

• The provided 510(k) summary does not mention a training set or its sample size. This type of device (fluorescence immunoassay) typically relies on chemical and biological parameters rather than machine learning models that require training sets in the same way.

9. How Ground Truth for the Training Set Was Established

• As no training set is mentioned for this device, information on how its ground truth was established is not applicable based on the provided document.

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The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.

This assay consists of two reagents and a calibrator.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Acetaminophen-SL Assay". This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

The information required to answer your request, such as detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and detailed performance metrics, is not present within this regulatory letter.

Therefore, I cannot extract the requested information from the provided text.

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The Bayer ADVIA IMS Acetaminophen method is an in vitro diagnostic device intended to measure acctaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose.

This in-vitro diagnostic method is intended to measure acetaminophen in human serum and plasma using lithium heparin as the anticoagulant on ADVIA® IMS™. Acetaminophen (Tylenol, paracetamol, p-hydroxyacetanilide) is used in many formulations as an analgesic, generally with no adverse effects. Measurement of acetaminophen is used in the diagnosis and treatment of severe liver damage caused by overdose through chronic usage, accident or self-infliction.

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 document doesn't explicitly state "acceptance criteria" in a formal, enumerated list. However, based on the performance data presented and the conclusion of equivalence to a predicate device, we can infer the implied acceptance criteria were met by showing comparable or better performance in the following areas:

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Imprecision (Serum): Not explicitly stated how many samples per level were used for CV calculation, but generally, this involves replicate measurements on multiple samples.
  • Correlation (Serum vs Abbott/TDx): 46 specimens
  • Correlation (Plasma vs Serum on ADVIA IMS): 50 specimens
  • Interfering Substances: A single Acetaminophen concentration was tested for each interferent, but the number of unique samples is not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies the studies were conducted by Bayer Corporation for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

This type of in-vitro diagnostic device (an assay for a chemical compound) typically does not rely on human experts to establish "ground truth" for the test set in the same way imaging devices do. The ground truth for such assays is established through:

• Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) or certified reference materials are used to assign true values to samples.
• Predicate Device Measurements: For comparison studies, the predicate device itself serves as a "ground truth" for the new device, assuming the predicate device is already validated and accepted.

The document does not mention any human experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this device's performance evaluation does not involve subjective interpretations requiring adjudication by experts. The ground truth for quantitative assays is based on analytical measurements.

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

No. This is an in-vitro diagnostic assay for measuring acetaminophen concentrations, not an imaging device or a device requiring human interpretation of results in a diagnostic imaging workflow. Therefore, an MRMC study is not relevant or performed for this type of device.

6. Standalone Performance

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS Acetaminophen method. The "Correlation" section specifically compares the new device's measurements (Y) against a known comparison system (X), which serves as a benchmark for its standalone accuracy.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily comparison to a legally marketed predicate device (Abbott/TDx) and likely reference methods or certified materials for establishing the validity of the predicate device and the new device's calibration and analytical range. For the interference study, the "true" acetaminophen concentration would have been precisely known when the interfering substance was added.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. For an in-vitro diagnostic assay of this nature, the development process typically involves:

• Method development and optimization.
• Calibration using a set of calibrators (the calibrator part number 04919015 is mentioned).
• Verification and validation studies using various types of samples to assess precision, accuracy, linearity, interference, etc.

There typically isn't a "training set" in the machine learning sense, as this is a chemical assay, not an AI/ML algorithm.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The calibration process for the assay would establish its measurement curve, and this would be based on precisely known concentrations of acetaminophen.

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For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.

The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen reagent kits.

Here's an analysis of the provided text regarding the Roche Acetaminophen Assay, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the Roche Acetaminophen Assay. However, it does present performance characteristics for comparison to the predicate device. For the purpose of this response, I will infer the acceptance criteria are implicitly defined by the acceptable performance compared to the predicate and the general requirements for such assays (e.g., adequate precision and method correlation).

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

• Test Set Sample Size:
  • For comparison against the Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700: N = 150
  • For comparison of the predicate device (Roche COBAS INTEGRA Acetaminophen) against the Abbott TDx Acetaminophen assay: N = 87 (This refers to data for the predicate, not the new device's primary test set)
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to this type of device. The Roche Acetaminophen Assay is an in vitro diagnostic (IVD) quantitative assay. Its "truth" is established by comparing its measurements to a reference method (the predicate device) or a gold standard method, not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this IVD assay. The comparison is based on quantitative analytical results.

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. The Roche Acetaminophen Assay is an IVD device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or classification tool that would involve human "readers."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance of the Roche Acetaminophen Assay, as described, is inherently a "standalone" performance in the context of an IVD. It generates a quantitative result without human intervention in the analytical process. The study described (method comparison) assesses this standalone analytical performance against a known method.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by comparing the results of the new Roche Acetaminophen Assay against a predicate device (Roche COBAS INTEGRA Acetaminophen Assay), which is itself an already validated and legally marketed device. In essence, the predicate serves as the reference method or "gold standard" for this comparative study.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of this chemical assay. Chemical assays are developed and validated through analytical studies, not typically machine learning training protocols.

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

This is not applicable as there is no training set described for this type of device.

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