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The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.

The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.

The Emit® tox™ Salicylic Acid Assay is intended for the quantitative analysis of salicylic acid in human serum or plasma to diagnose and treat salicylic acid overdose or monitor therapeutic levels.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers.

The Emit® II Plus Monoclonal Amphetamine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

The provided text is a 510(k) summary for the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. It establishes the device's substantial equivalence to a predicate device and states its intended use. However, it does not include detailed acceptance criteria, a study demonstrating performance against those criteria, or the specific information requested in the prompt regarding sample sizes, ground truth establishment, or clinical study designs.

Therefore, most of the information requested cannot be extracted from this document. The document primarily focuses on regulatory approval based on equivalence rather than presenting a performance study with detailed acceptance criteria.

Here's what can be inferred or explicitly stated from the provided text, and what cannot:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity thresholds) nor report detailed performance metrics against such criteria. It states that the "assay performance characteristics" are the same as the predicate device, implying that the predicate device's performance would be the reference, but no specific numbers are given.

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

• Cannot be provided. The document does not describe a new performance study with a test set. The submission is based on the device being substantially equivalent to a predicate device, with minor changes primarily related to packaging and compatibility with different analyzers.

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)

• Cannot be provided. No new test set is described, so no information on experts or ground truth establishment for such a set is present.

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

• Cannot be provided. No new test set or adjudication method is described.

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

• Cannot be provided. This device is an in-vitro diagnostic (IVD) assay for drug detection, not an AI-assisted diagnostic tool that would involve human readers interpreting results in a comparative effectiveness study.

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

• Cannot be provided. While an IVD assay functions "standalone" without human interpretation in the sense of a clinical reader, the document does not present results of a standalone performance study with specific metrics. It relies on the substantial equivalence to an existing device.

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

• Cannot be provided for a new study. For drug-of-abuse assays, the "ground truth" for confirming positive results typically involves more specific analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document mentions GC/MS as the preferred confirmatory method for preliminary positive results, implying how clinical ground truth would be established for patient samples, but not for a specific device validation study described in this document.

8. The sample size for the training set

• Not applicable/Cannot be provided. This is an enzyme immunoassay, not a machine learning model. There is no concept of a "training set" in the context of this device.

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

• Not applicable/Cannot be provided. As above, no training set.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a minor modification (packaging and analyzer compatibility) of an existing in-vitro diagnostic device. It does not describe or report the outcomes of a new performance study that would establish new acceptance criteria or detailed performance metrics.

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The Emit® 2000 Valproic Acid Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of valproic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of valproic acid overdose or in monitoring levels of valproic acid to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

The provided document, K011947, is a 510(k) summary for the Emit® 2000 Valproic Acid Assay. It describes a modified assay that is primarily a packaging change compared to a predicate device. The core assay performance characteristics are stated to be the same as the predicate device. This is a crucial point, as much of the performance data relies on the equivalence to the predicate.

Given this context, the document does not explicitly state specific numerical acceptance criteria for the modified device's performance, nor does it detail a standalone study generating new performance metrics for this specific modified version. Instead, the submission relies on the assertion that the "assay performance characteristics" are identical to the predicate device. Therefore, the "reported device performance" for the modified device is implicitly assumed to be the same as the predicate.

The document focuses on substantiating that the packaging changes do not alter performance.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific numerical acceptance criteria for the modified device's analytical performance (e.g., accuracy, precision, linearity) are not explicitly stated in this 510(k) summary. The submission argues for substantial equivalence based on the modified device having the "same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, the de facto acceptance criteria are that the modified device's performance is demonstrably unchanged from the predicate device due to the packaging modifications, or that it continues to meet the performance established for the predicate.

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

The 510(k) summary does not provide details for a specific test set with sample sizes for the modified device's performance. The submission is based on the premise that the assay capabilities are identical to the predicate. The "study" here is more of a comparison of device characteristics rather than a new performance study.

• Sample Size for Test Set: Not specified, as no new performance study data is presented for the modified device itself.
• Data Provenance: Not applicable in the context of new performance data for the modified device. The "data" refers to the established equivalence of the components and the assay principles.

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

Not applicable. This device is an in-vitro diagnostic (IVD) assay for measuring a specific analyte concentration. Ground truth for such assays is typically established through a reference method or validated calibrators, not through human expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD assay measuring an analyte, there is no "adjudication method" in the sense of expert review for ambiguous cases. Performance is typically assessed through analytical validation (e.g., linearity, precision, accuracy against reference methods).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for devices involving human interpretation (e.g., medical imaging devices). This is an IVD assay, not requiring human interpretation of complex outputs.

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

Yes, in an implicit sense. The "device" (the reagents) functions as an automated system on an analyzer. The intent of the submission is to demonstrate that the reagents themselves perform identically to the predicate reagents, without human intervention affecting the analytical result. The performance of the predicate device would have been established as a standalone analytical system.

7. The Type of Ground Truth Used

For the predicate device (and by extension, the modified device), the ground truth for Valproic Acid concentration would typically be established by:

• Reference Methods: Such as Gas Chromatography-Mass Spectrometry (GC-MS) or High-Performance Liquid Chromatography (HPLC), which are highly accurate and precise methods for determining drug concentrations.
• Certified Reference Materials/Calibrators: Solutions with known, traceable concentrations of Valproic Acid.

8. The Sample Size for the Training Set

No "training set" in the machine learning sense is described or applicable. This is a chemical assay, not an AI/ML algorithm. The assay's "design" is based on established biochemical principles (enzyme immunoassay).

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

Not applicable, as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the development of such an assay would refer to the validation of its analytical characteristics using reference methods and certified calibrators, as mentioned in point 7.

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The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Emit® 2000 Digoxin Assay, and it primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details. The only relevant information gathered from the text is:

• Device Name: Emit® 2000 Digoxin Assay
• Intended Use: Quantitative analysis of digoxin in human serum or plasma. Used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy.
• Nature of comparison: The modified assay is similar to the predicate device with minor differences in the packaging (smaller fill volume, different shaped reagent bottles, barcode label compatible with OLYMPUS® AU analyzers). The manufacturer states, "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." This suggests performance characteristics are assumed to be a match to the predicate, rather than independently proven, for the purpose of this 510(k).

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The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

The provided text is a 510(k) summary for the Emit® 2000 N-Acetylprocainamide Assay, a diagnostic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that the modified device is similar to an already approved predicate device, with minor packaging differences.

Therefore, the typical structure for reporting acceptance criteria and a study proving their achievement is not directly applicable in this context. The document emphasizes that the "modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." This implies that the performance characteristics (e.g., accuracy, precision, linearity) are expected to be the same as the predicate device, and the demonstration of substantial equivalence serves as the "proof."

However, I can extract information related to what would be considered "performance" in such a context, even if the detailed study results aren't explicitly provided in this summary.

Here's an attempt to answer your questions based on the provided text, acknowledging its limitations:

Acceptance Criteria and Study for Emit® 2000 N-Acetylprocainamide Assay

Based on the provided 510(k) summary (K011620), the primary "acceptance criteria" for the modified Emit® 2000 N-Acetylprocainamide Assay relate to its substantial equivalence to an existing predicate device. The underlying assumption is that the predicate device's performance already meets established clinical and analytical requirements. The study here essentially demonstrates that the minor changes (packaging, bottle size, barcode) do not negatively impact the assay's performance characteristics.

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

Since this is a 510(k) for a modified device emphasizing substantial equivalence due to minor packaging changes, explicit quantitative acceptance criteria for primary diagnostic metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this summary for the modified device. Instead, the "performance" demonstrated is that the re-packaged device maintains the "same assay performance characteristics" as the predicate device.

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

The 510(k) summary does not provide specific details about the sample size, type (e.g., patient samples vs. spiked controls), or provenance of a test set used to explicitly re-evaluate performance characteristics for this modified device. The declaration of "same assay performance characteristics" suggests that validation was performed, but the specifics are not included in this high-level summary. Given the nature of a chemical assay, it would typically involve prospective testing with controlled samples or clinical specimens.

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)

Not applicable. For an in vitro diagnostic assay like this (measuring N-Acetylprocainamide levels), "ground truth" is established through highly accurate reference methods or clinical outcomes, not typically by expert consensus of imaging or pathology. The determination of N-Acetylprocainamide levels is an objective measurement.

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

Not applicable. This is not a study requiring human adjudication of results in the conventional sense (e.g., for image interpretation). Analytical measurements are typically verified against established standards or validated reference methods.

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

Not applicable. This is an automated immunoassay, not a device involving human readers or AI assistance.

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

This is a standalone algorithm/device. The Emit® 2000 N-Acetylprocainamide Assay is an automated immunoassay system (reagents used on OLYMPUS® analyzers) that quantitatively measures N-Acetylprocainamide. Its performance is entirely determined by the chemical reaction and instrument measurement, without human interpretive input affecting the fundamental result.

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

For an in vitro diagnostic test measuring a specific analyte, "ground truth" (or analytical true value) is typically established by:

• Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) that are considered the gold standard.
• Certified Reference Materials: Solutions with known, certified concentrations of the analyte.
• Interlaboratory Comparisons: Though less about "ground truth" and more about comparative performance.

While not explicitly stated in the summary, given it's an assay for N-Acetylprocainamide, the ground truth would have been established using one or a combination of these analytical approaches.

8. The sample size for the training set

Not applicable. This is a chemical immunoassay, not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The "training" of the assay system itself comes from its chemical design and optimization steps during development, and calibration against known standards.

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

Not applicable, as there isn't a "training set" in the machine learning sense. The assay's analytical performance (linearity, precision, accuracy) is calibrated and validated using reference materials or samples with known, analytically determined concentrations (as described in point 7).

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The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles, Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

This document does not contain the detailed information necessary to fully answer all aspects of your request. The provided text is a 510(k) summary for a medical device, which primarily focuses on establishing substantial equivalence to a predicate device rather than providing a comprehensive study report with acceptance criteria and detailed performance data.

Here's an analysis of what can be extracted and what is missing:

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

This information is not present in the provided document. A 510(k) summary typically references that performance characteristics are similar to the predicate device but does not usually include a table of specific acceptance criteria and the detailed results of a new study against those criteria.

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. The summary states "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device," implying that new, extensive clinical studies for this specific modification were not deemed necessary for substantial equivalence.

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 device is an in vitro diagnostic for quantitative analysis of quinidine. The "ground truth" for such devices is typically established through a reference measurement method or certified calibrators, not through human expert consensus in the same way an imaging device might use a radiologist.

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

This information is not present in the provided document. As a quantitative immunoassay, adjudication by human experts in the described manner is not applicable.

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 to this device. The Emit® 2000 Quinidine Assay is an automated in vitro diagnostic immunoassay for quantitative analysis, not an AI-assisted diagnostic imaging or human-read system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this technology.

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

This information is not explicitly detailed in the document as a "standalone study." However, the device itself is a standalone quantitative assay. It functions as an algorithm (the immunoassay process) providing a numerical result, without requiring human interpretation of complex patterns, thus not fitting the typical "algorithm only without human-in-the-loop performance" in the context of imaging or AI. Performance characteristics for such an assay would typically include precision, accuracy, linearity, and interference studies. The summary implies these are "the same... performance characteristics" as the predicate device.

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

The "ground truth" for a quantitative diagnostic assay like this is typically established by comparing results to a reference method (e.g., GC-MS, LC-MS/MS) or by using certified reference materials/calibrators with known concentrations. The document does not specify the exact method used for the original predicate device or for validating this modified version.

8. The sample size for the training set

This is not applicable and not present in the document. This device is an immunoassay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve optimizing assay reagents and conditions, which is part of its manufacturing and design, not typically reported as a "training set" size in a 510(k) summary.

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

This is not applicable and not present for the reasons stated in point 8.

Summary of Device and Study (as far as discernible from the document):

• Device Name: Emit® 2000 Quinidine Assay
• Intended Use: Quantitative analysis of quinidine in human serum or plasma for diagnosis/treatment of overdose or monitoring therapy.
• Device Description: Homogeneous enzyme immunoassay. The modification described in this 510(k) pertains to minor packaging differences (smaller fill volume, different shaped bottles, barcode label) and compatibility with specific OLYMPUS® analyzers, while the assay chemistry and performance are stated to be "the same" as the predicate.
• Study: This 510(k) filing primarily relies on demonstrating substantial equivalence to a predicate device (the original Emit® 2000 Quinidine Assay). No detailed new performance study data for this specific packaging modification is provided in the summary. The assertion is that "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, the "study" for this 510(k) seems to be a demonstration that the changes do not affect the established performance characteristics.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device