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510(k) Data Aggregation
(79 days)
LBZ
The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.
The QMS® Quinidine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS® Quinidine Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.
The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the The absorbance of unknown samples can be interpolated from the absorbance values of the drug, calibration curve and the concentration of the drug present in the sample can be calculated.
The assay consists of reagents R1: anti-quinidine monoconal and R2: quinidine-oated microparticles. A six-level set of QMS® Quinidine Calibrators (A throu
Here's a breakdown of the acceptance criteria and study information for the QMS® Quinidine assay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (% Recovery) | 100% ± 10% | Mean Percent Recovery: 97.71% (for spiked samples) |
| Linearity (R²) | Not explicitly stated as a numerical AC, but implied good linearity | 0.9995 (correlation coefficient for linear regression) |
| Sensitivity (LDD) | Claim of 0.2 µg/mL supported | Average LDD: 0.09 µg/mL |
| Assay Range | Based on Accuracy, Linearity, Sensitivity | 0.2 to 8.0 µg/mL |
| Precision (Total CV) |
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(167 days)
LBZ
The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the numan sorant of practicular arththmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic supraventicular (urrry annos) formulation, patient age, and individual variability in 2010, 0 Scruit levels is depondent on the proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.
The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
Below is a summary of the acceptance criteria and study information for the Roche ONLINE Quinidine Assay, based on the provided text.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in the provided text. However, the study aims to demonstrate substantial equivalence to a predicate device (Roche COBAS INTEGRA Quinidine Assay) and an Enzyme Immunoassay by showing comparable precision and method correlation. The reported device performance is presented in comparison to these predicate methods.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Roche ONLINE TDM Quinidine Reported Performance |
|---|---|---|
| Method Comparison | Versus Roche COBAS INTEGRA Quinidine Assay | |
| Correlation (R) | 0.991 (Predicate) | 0.991 |
| Regression (Y=mX+b) | Y = 1.054X - 0.036 (Predicate) | Y = 1.054X - 0.036 |
| Range | 0.16 to 5.7 µg/mL (Predicate) | 0.22 to 7.04 µg/mL |
| Versus Enzyme Immunoassay | ||
| Correlation (R) | 0.991 (Predicate) | 0.991 |
| Regression (Y=mX+b) | Y = 0.941X - 0.024 (Predicate) | Y = 0.941X - 0.024 |
| Range | Not explicitly stated for EIAA | 0.16 to 5.7 µg/mL |
| Precision (Level 1) | ||
| Mean (µg/mL) | 1.35 (Predicate) | 0.93 |
| CV% (within run) | 2.1 (Predicate) | 2.0 |
| CV% (total) | 3.2 (Predicate) | 3.9 |
| Precision (Level 2) | ||
| Mean (µg/mL) | 3.47 (Predicate) | 2.87 |
| CV% (within run) | 2.2 (Predicate) | 1.3 |
| CV% (total) | 3.5 (Predicate) | 2.7 |
| Precision (Level 3) | ||
| Mean (µg/mL) | 5.42 (Predicate) | 4.61 |
| CV% (within run) | 2.0 (Predicate) | 1.2 |
| CV% (total) | 3.2 (Predicate) | 2.7 |
2. Sample Size and Data Provenance for the Test Set
- Sample Size (Method Comparison):
- N = 150 (for comparison against Roche COBAS INTEGRA Quinidine Assay)
- N = 154 (for comparison against Enzyme Immunoassay)
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not applicable as the device is an in-vitro diagnostic assay for quinidine quantification, not an imaging or diagnostic AI with subjective interpretation requiring human experts for ground truth establishment. The performance is assessed against established laboratory methods.
4. Adjudication Method (Test Set)
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiologists reading images), which is not the case for this automated immunoassay.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the "Roche ONLINE TDM Quinidine" assay itself, in comparison to other existing assays. There is no mention of human-in-the-loop performance; the device is automated for quantitative determination.
7. Type of Ground Truth Used
The ground truth used for comparison was the results obtained from:
- The Roche COBAS INTEGRA Quinidine Assay (predicate device).
- An Enzyme Immunoassay.
The performance of these established methods served as the reference for determining the new device's accuracy and precision.
8. Sample Size for the Training Set
The provided text does not contain information regarding a specific training set or its sample size. This type of submission (510(k) for an in-vitro diagnostic) focuses on validation and comparison to a predicate, rather than the development and training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing its ground truth is not applicable from the provided text.
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(19 days)
LBZ
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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(70 days)
LBZ
This in vitro method is intended to quantitatively measure Quiniciding drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-10 system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.
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Here's an analysis of the provided text regarding the Quinidine Method for Bayer Technicon Immuno 1 System, structured according to your request:
Acceptance Criteria and Device Performance Study
The provided document describes a comparison study rather than an explicit set of acceptance criteria for a new device. However, by comparing the performance of the Immuno 1 Quinidine method to a previously cleared predicate device (Syva EMIT® 2000 Quinidine Assay), the "acceptance criteria" can be inferred as demonstrating comparable performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Inferred Acceptance Criteria (Based on Predicate Device) | Reported Immuno 1 Quinidine Performance |
|---|---|---|
| Minimum Detectable Conc. | ≤ 0.25 µg/mL | 0.06 µg/mL |
| Precision (Between-Run) | 1.5 µg/mL: ≤ 6.5% CV | 1.2 µg/mL: 5.5% CV |
| (Between-Run) | 3.4 µg/mL: ≤ 5.2% CV | 3.5 µg/mL: 4.8% CV |
| (Between-Run) | 5.7 µg/mL: ≤ 5.6% CV | 6.0 µg/mL: 5.3% CV |
| Correlation (vs. Predicate) | High correlation (e.g., r > 0.95 and slope ≈ 1, intercept ≈ 0) | y = 1.02x - 0.16, r = 0.991, Syx = 0.148 µg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Initial sample size for the correlation study was
n = 25. An additional number of patients were requested, and data was provided in a 11/26/96 memo, which reportedly caused "no significant change in correlation." The exact total sample size after the addition is not specified, but it's more than 25. - Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that the data was collected and then analyzed for submission, typical for a comparison study to a predicate. The samples were human serum or plasma.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This study does not involve expert-established ground truth in the traditional sense of diagnostic imaging or clinical consensus. The "ground truth" for the comparison is the measurement obtained from the predicate device (Syva EMIT® 2000 Quinidine Assay).
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method (like 2+1, 3+1) was used as the ground truth was established by the predicate device's measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This is a comparison of analytical performance between two laboratory assays, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, this study inherently describes the standalone performance of the Immuno 1 Quinidine method (the "algorithm" in this context refers to the assay's methodology). Its measurements are compared directly to the predicate device's measurements.
7. The Type of Ground Truth Used
The ground truth used for the comparison study was the measurements obtained from the predicate device, the Syva EMIT® 2000 Quinidine Assay. This is a form of "reference method" comparison, where the predicate serves as the established and accepted measurement technique.
8. The Sample Size for the Training Set
Not applicable. This document describes a validation study for an in vitro diagnostic (IVD) assay, not a machine learning model that requires a distinct training set. The assay itself is a chemical-biological system, not an algorithm that learns from training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of this IVD assay's development and validation.
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(57 days)
LBZ
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(120 days)
LBZ
Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.
The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.
Not Found
Here's a breakdown of the provided information concerning the INNOFLUOR™ Quinidine Assay System (Modified), structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Existing Devices: | Demonstrated: The INNOFLUOR™ Quinidine Assay System (Modified) is deemed substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay in terms of technological characteristics, performance, and intended use. |
| Linear Regression - Slope: | 0.958 |
| Linear Regression - Intercept: | -0.077 |
| Correlation Coefficient (r): | 0.986 |
| Assumed Implied Acceptance Range for Slope: (Not explicitly stated, but typically close to 1) | 0.958 (within an acceptable range around 1, though not specified here) |
| Assumed Implied Acceptance Range for Intercept: (Not explicitly stated, but typically close to 0) | -0.077 (within an acceptable range around 0, though not specified here) |
| Assumed Implied Acceptance Range for Correlation Coefficient (r): (Not explicitly stated, but typically high, close to 1) | 0.986 (demonstrates strong correlation) |
Note: The document explicitly states "Substantial equivalence has been demonstrated." While specific numerical acceptance thresholds for slope, intercept, and correlation coefficient are not explicitly provided in the input, the reported values are presented as evidence supporting this claim of substantial equivalence. For a medical device, these metrics being close to 1 (for slope and correlation) and 0 (for intercept) are generally considered indicative of good agreement between methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 49 serum patient samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "patient samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for this performance study is established by a reference assay (the Abbott Quinidine Assay), not by human expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation is involved in establishing a ground truth or resolving discrepancies between reviewers. In this case, the comparison is between two analytical assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The provided study focuses on comparing the output of an automated assay system directly against a reference assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The INNOFLUOR™ Quinidine Assay System (Modified) is an automated assay system. Its performance was evaluated directly against a reference assay (Abbott Quinidine Assay) without human intervention in the analysis process beyond initiating the test and reading the results.
7. The Type of Ground Truth Used
The "ground truth" in this study is established by the Abbott Quinidine Assay. This is a reference standard or comparator method rather than one of the typical ground truth categories like "expert consensus" or "pathology" for diagnostic imaging. The performance of the modified INNOFLUOR™ system is being evaluated relative to this established, existing assay.
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. This suggests that the INNOFLUOR™ Quinidine Assay System (Modified) is likely a re-formulation or modification of an existing assay, and its performance is being compared to established methods rather than being an AI algorithm that requires a distinct training phase in the typical sense. If there was any "training" involved, it would be in the initial development and calibration of the assay, but the document does not detail this.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its "ground truth" was established is also not applicable/not documented in the provided summary.
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