Search Results

The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Dade Behring Dimension VistaTM Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension VistaTM 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.

The provided text describes a 510(k) submission for several Dimension Vista™ Flex® reagent cartridges intended for diagnostic testing. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a packaging modification that allows these reagents to be used on the Dimension Vista™ integrated system. The reagents themselves and their fundamental scientific technology are stated to be the same as the predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" or provide a table of "reported device performance" in the typical sense of a clinical study (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the demonstration of performance relies on comparative testing to show substantial equivalence to the predicate devices. The implicit acceptance criterion is that the performance of the new Dimension Vista™ Flex® reagent cartridges must be substantially equivalent to that of the predicate Dimension® Flex® reagent cartridges.

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

Since the document is a summary and not the full study protocol, specific performance metrics and their comparison values are not detailed. However, the nature of these in-vitro diagnostic tests typically involves:

• Precision/Reproducibility: Measuring the consistency of results when the same sample is tested multiple times.
• Accuracy/Method Comparison: Comparing the results obtained by the new device against a reference method (in this case, the predicate device results) using patient samples. This often involves statistical methods like regression analysis (e.g., Deming regression) to assess agreement.
• Linearity/Measuring Range: Confirming that the device accurately measures analytes across its claimed analytical range.
• Interference Studies: Assessing the impact of common interfering substances (e.g., hemoglobin, bilirubin, lipids) on the test results.

The key takeaway is that the "acceptance criteria" here are defined by the established performance characteristics of the predicate devices, and the new devices are deemed acceptable if their performance is statistially similar.

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." However, it does not specify the sample size used for the comparative testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

This information is not applicable in the context of this 510(k) submission. For in-vitro diagnostic (IVD) devices measuring specific analytes, the "ground truth" is typically the quantitative concentration of the analyte as determined by a reference method or the predicate device itself, not by expert consensus on qualitative interpretation. No human experts are described as establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the submission concerns quantitative measurements of chemical analytes, there is no need for an adjudication method as would be relevant for subjective medical image interpretation or clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

This information is not applicable. The device is an in-vitro diagnostic reagent cartridge for laboratory analysis, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The entire "device" described here (the reagent cartridges used on an automated analyzer) operates in a standalone (algorithm/system only) manner in terms of its measurement process. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents enable this automated system to perform the quantitative measurements without direct human intervention in the measurement execution. Human involvement is in sample preparation, loading, and interpretation of the numerical results delivered by the automated system.

7. The Type of Ground Truth Used:

The ground truth for the performed comparative testing would have been the quantitative concentration of the specific analyte (Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, Theophylline) as measured by the predicate device. Since the reagents themselves are stated to be the same as the predicate and only the packaging is modified for a new instrument system, the primary ground truth is established by the well-characterized performance of the predicate device on its intended system for each analyte.

8. The Sample Size for the Training Set:

This document does not mention a "training set" in the context of an algorithm or machine learning model. This is expected as the device is a reagent cartridge for a chemical assay, not a machine learning-based diagnostic. Therefore, information about the training set size is not applicable.

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

As there is no "training set" in the machine learning sense, this information is not applicable. The "training" of such a system involves the development and optimization of the chemical assay reagents and the instrument's detection capabilities during the initial development phases of the predicate devices and the Dimension Vista™ analyzer itself.

Ask a specific question about this device

Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic immunoassay for the quantitative determination of digitoxin in serum. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin in the serum and in monitoring levels of digitoxin to ensure appropriate therapeutic levels.

The method includes a suspension of measuring particles coated with digitoxin conjugate. When a sample containing digitoxin is added, the digitoxin in the sample competes with the digitoxin conjugate on the particles for the limited amount of antibody in the reagent. The respective amounts of antibody bound to the digitoxin in the sample and to the digitoxin conjugate on the particles are inversely dependent on the concentration of digitoxin in the sample. The amount of antibody bound to the particles is measured by the agglutination process. When the antibody binds to the particles, agglutination occurs. When digitoxin is present in the sample, partial inhibition of the agglutination process occurs. The degree of agglutination is measured as a change in scattered light as a change in absorbance, proportional to the concentration of digitoxin in the sample.

The provided text is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. regarding their Digitoxin test system. While it indicates that the device has been found substantially equivalent to a legally marketed predicate device, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This document is a regulatory approval, not a scientific study report.

Ask a specific question about this device

The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

The digitoxin assay uses an immunoassay technique in which free and digitoxin-bound antibody-enzyme species are separated using magnetic particles. Digitoxin in the sample is bound by the F(ab')2-ß-galactosidase in the Antibody Conjugate reagent. Magnetic particles coated with the digitoxin analog ouabain are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the digitoxin-antibody-enzyme complex is transferred and mixed with a substrate. The ß-galactosidase (ß-gal) portion of the Digoxin-F(ab')2-βgalactosidase complex catalyzes the hydrolysis of chlorophenol red-β-D galactopyranoside (CPRG) to chlorophenol red (CPR). The change in absorbance at 577 nm due to the formation of CPR is directly proportional to -B-galactosida: e activity. Since ß-galactosidase is not present in serum, its activity is directly proportional to di ¿itoxin in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Study Details for DGTX Flex™ Reagent Cartridge

1. Acceptance Criteria and Reported Device Performance

The provided document defines substantial equivalence based on the correlation with a predicate device. The primary acceptance criteria are derived from this comparative study.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 93 clinical patient samples.
• Data Provenance: The document does not explicitly state the country of origin. However, the submission is to the U.S. FDA, and the product is intended for the U.S. market, suggesting the data is likely relevant to the U.S. patient population if not collected therein. The data is retrospective, as it's a "split sample comparison" using existing clinical patient samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications to establish ground truth for the test set.

4. Adjudication Method

The document does not specify an adjudication method. In a split-sample comparison for an analytical device, the "ground truth" is typically the result from the predicate device itself, or a reference method that the predicate device was previously validated against.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers provide an assessment. The DGTX Flex™ is an in vitro diagnostic reagent cartridge for quantitative measurement, not a device requiring human interpretation of images or complex data.

6. Standalone Performance Study

Yes, a form of standalone performance was conducted, but it's framed as a comparison to a predicate device, not as an absolute standalone validation against a gold standard that is independent of any existing device. The correlation study directly assesses the performance of the DGTX Flex™ reagent cartridge on the Dimension® clinical chemistry system.

7. Type of Ground Truth Used

The ground truth for the test set was the results obtained from the predicate device, the aca® DGTX assay. This is evident from the "split sample comparison," where both the new device and the predicate device analyzed the same clinical samples, and the predicate's results served as the reference for comparison.

8. Sample Size for Training Set

The document does not specify a training set size. For an IVD reagent, method development typically involves extensive internal validation and optimization, but a distinct "training set" in the context of machine learning (where this term is often used) is not applicable here. The "93 clinical patient samples" refer to the test set used for the substantial equivalence comparison.

9. How Ground Truth for Training Set Was Established

As no specific training set is mentioned in the context of the substantial equivalence claim, the method for establishing its ground truth is not applicable/not provided in this document. During the development of the assay, calibration and internal validation would have been performed using methods established for quantitative assays, likely involving certified reference materials or highly characterized samples.

Ask a specific question about this device

The Chiron Diagnostics ACS:180 Digitoxin Assay is for the quantitative determination of digitoxin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence System. Monitoring of serum digitoxin concentrations is necessary to maintain therapeutic efficacy and avoid toxicity. Serum digitoxin levels combined with other therapeutic and clinical information provide the clinician with useful information to aid in adjusting patient dosage, achieving optimal therapeutic effect, and avoiding useless subtherapeutic or harmful toxic doses.

The Chiron Diagnostics ACS:180 Digitoxin assay is a competitive immunoassay using direct, chemilumenescent technology. Digitoxin in the patient sample competes with digitoxin, which is covalently coupled to the paramagnetic particles in the Solid Phase for binding to the acridinium ester-labeled monoclonal anti-digitoxin antibody in the Lite Reagent. An inverse relationship exists between the amount of digitoxin in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

The provided document describes the Chiron Diagnostics ACS Digitoxin assay, comparing its performance to an alternate fluorescence polarization (FPIA) method.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document
does not explicitly state "acceptance criteria" values for correlation coefficient, slope, or intercept. These are inferred from the presentation of the data as supporting the device's accuracy and substantial equivalence.

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

• Sample Size for Test Set: 608 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a submission to the FDA, it's highly likely to be clinical samples, though the specifics are not provided.

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 document. The "ground truth" for the test set is established by the "alternate fluorescence polarization (FPIA) method," which is itself a diagnostic assay. The document doesn't detail the development or validation of this FPIA method.

4. Adjudication Method for the Test Set

• This information is not applicable/provided in the context of this type of analytical validation. The comparison is against an instrumental method (FPIA), not a human-adjudicated ground truth.

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 device is an automated immunoassay for measuring a chemical substance (digitoxin concentration) in serum/plasma, not an imaging device or a diagnostic tool requiring human interpretation or AI assistance in that sense.

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

• Yes, the performance data presented is for the standalone algorithm (ACS Digitoxin immunoassay). The "accuracy" and "sensitivity" are inherent properties of the assay system itself, not dependent on human interpretation of the assay results in a "human-in-the-loop" setting.

7. The Type of Ground Truth Used

• The "ground truth" (or reference method) for the performance study was an alternate fluorescence polarization (FPIA) method. This is a laboratory diagnostic method.

8. The Sample Size for the Training Set

• The document does not specify a training set sample size. For an immunoassay, the "training set" concept is usually associated with the development and calibration of the assay itself, not a separate, explicitly defined "training set" as might be seen in machine learning applications. The 608 samples are described as involved in the "accuracy" study comparing to the alternate method.

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

• As a "training set" is not explicitly defined or described in the context of this submission, the method for establishing its "ground truth" is not provided. The FPIA method serves as the reference standard for the performance evaluation.

Ask a specific question about this device

for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate).

automated fluorescence polarization immunoassays (FPIA).

Given the provided text, the device is an in-vitro diagnostic (IVD) assay, specifically the Abbott AxSYM® Digitoxin assay, and the "acceptance criteria" and "study" refer to the validation performed for its substantial equivalence determination.

Here's a breakdown of the information requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the text doesn't explicitly state numerical thresholds but rather presents the results as evidence of substantial equivalence, indicating these values were considered acceptable.

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

• Sample Size: 517 (This refers to the number of samples used in the "Correlation studies").
• 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 the qualifications of those experts

This section is not applicable to this type of IVD study based on the provided text.

• The "ground truth" for an IVD correlation study like this isn't established by human experts interpreting images or clinical cases. Instead, it's typically established by a reference method (in this case, the predicate device, TDx/TDxFLx Digitoxin assay) or gravimetric purity for calibrators/controls.

4. Adjudication method for the test set

This section is not applicable to this type of IVD study based on the provided text.

• Adjudication methods (like 2+1 or 3+1) are common in studies involving human interpretation of data (e.g., imaging studies where multiple readers interpret a scan). For a quantitative IVD assay correlation, "adjudication" in this sense is not performed. The comparison is objective, based on numerical results from two different automated assays.

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 section is not applicable to this type of study.

• This is an IVD assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance metrics are irrelevant.

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

Yes, a standalone performance was done.

• The "Abbott AxSYM® Digitoxin assay" is an automated fluorescence polarization immunoassay (FPIA) system. Its performance is measured independently of human interpretation of individual assay results, and it directly outputs quantitative digitoxin levels.

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

The "ground truth" for the correlation study reported (comparing AxSYM to TDx/TDxFLx) is the predicate device's measurements (TDx/TDxFLx Digitoxin assay).

• For the calibrators and controls used by the AxSYM Digitoxin assay, the ground truth is established by gravimetric preparation using purified material obtained from commercial sources.

8. The sample size for the training set

The text does not explicitly mention a separate "training set" for the AxSYM Digitoxin assay.

• For IVD assays, particularly those developed before the widespread use of machine learning, the "training" analogous to ML models involves optimizing reagents, calibration curves, and analytical parameters. This is typically done through iterative development and testing, not a distinct "training set" in the machine learning sense. The 517 samples mentioned are for the correlation study between the new and predicate devices.

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

As there's no explicitly defined "training set" in the machine learning sense for this IVD, this question is not directly applicable.

• However, for the key components of the assay (calibrators and controls), the ground truth (their assigned values) is established through gravimetric preparation using purified material and subsequent verification using protocols involving multiple instrument testing.

Ask a specific question about this device