Search Results

The ADVIA Centaur EBV-EBNA IgG (EBVnaG) assay is for in vitro diagnostic use in the qualitative detection of IqG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

Not Found

The provided text describes the performance of the ADVIA Centaur EBV-EBNA IgG assay, an in vitro diagnostic device for the qualitative detection of IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA).

Here's an analysis of the acceptance criteria and study data:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ADVIA Centaur EBV-EBNA IgG assay are primarily demonstrated through its agreement with an FDA-cleared reference EBV EBNA IgG assay. While explicit "acceptance criteria" are not listed with numerical thresholds in a dedicated table, the clinical study results (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA) are implicitly compared against an expectation of substantial equivalence to the predicate device.

For precision and reproducibility, specific targets are mentioned.

2. Sample Size and Data Provenance

Clinical Study (Test Set):

• Total Study Population (Population 1): 1428 leftover samples.
  • Provenance: Collected over a contiguous time period from individuals for whom an EBV test was ordered. The document does not specify the country of origin but implies a clinical setting ("symptoms and signs for whom an EBV antibody test was ordered"). It is a retrospective collection of leftover samples.
• Known EBV EBNA IgG Negative Population (Population 2): 167 samples.
  • Provenance: Samples with a known EBV EBNA IgG negative result, used to supplement numbers for negative EBV EBNA IgG. Retrospective.
• Pediatric Population: Subsets of Population 1 (479 samples including 84 unclassified serostatus individuals) and Population 2 (72 samples including 6 unclassified serostatus individuals).
• Cross-reactivity Study: 330 samples across various clinical categories.
• Specimen Equivalency Study: 97-98 sets of matched samples (SST, EDTA plasma, lithium heparin plasma).
  • Provenance: Commercial sources.

3. Number of Experts and Qualifications for Ground Truth

The document explicitly states that the ground truth for the clinical study was established by an "FDA cleared EBV EBNA IgG reference assay."
It also states: "Equivocal reference assay results were resolved by 2 other comparative assays."

• Number of 'Experts' (resolving assays): 2 (for equivocal cases from the primary reference assay).
• "Qualifications" of these 'experts': These were "comparative assays" rather than human experts. The document does not specify if these were other FDA-cleared assays or the nature of their qualification, but the implication is that they served as a consensus mechanism to resolve indeterminate results from the primary reference assay.

4. Adjudication Method for the Test Set

The adjudication method for equivocal results from the primary reference assay was by "2 other comparative assays." This is a form of 2+0 or 1+2 (primary reference + 2 comparative). If the two comparative assays agreed, that likely established the reconciled ground truth for the equivocal samples. The document does not describe what happened if the two comparative assays disagreed.

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

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, which typically does not involve human readers interpreting images or data alongside AI. The device is evaluated for its analytical and clinical performance against a reference method. Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm only without human-in-the loop performance)

Yes, a standalone performance study was done. The entire clinical study, precision, reproducibility, specimen equivalency, and interference studies evaluate the performance of the ADVIA Centaur EBV-EBNA IgG assay as a standalone device (algorithm/assay only) against a reference method or predetermined analytical specifications. There is no human-in-the-loop component described for its primary intended use and evaluation.

7. Type of Ground Truth Used

The ground truth used for the clinical study was based on an FDA-cleared EBV EBNA IgG reference assay, with equivocal results resolved by 2 other comparative assays. This indicates a reference method or comparative assay-based ground truth.

8. Sample Size for the Training Set

The document is a 510(k) summary for an in vitro diagnostic assay. It does not provide information regarding a "training set" in the context of machine learning or AI models.
The samples mentioned are for performance evaluation (clinical study, precision, etc.) and are analogous to test or validation sets. For IVD devices, a "training set" might refer to samples used during the development and optimization of the assay's reagents and parameters, but this information is not typically disclosed in a 510(k) summary in this format.

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

As there is no "training set" described in the context of an AI/ML model for this IVD assay according to the provided document, this information is not applicable and not available.

Ask a specific question about this device

The ADVIA Centaur EBV-VCA IgM (EBVM) assay is for in vitro diagnostic use in the qualitative detection of lgM antibodies to the viral capsid antigen (VCA) of the Epstein-Barr virus (EBV) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

The ADVIA Centaur EBV-VCA IgM assay is a fully automated 2-step sandwich immunoassay using acridinium ester chemiluminescent technology. The specimen is incubated with the Ancillary Well Reagent and the Solid Phase, which contains an EBV-VCA IgM specific antigen. Antigen-antibody complexes will form if anti EBV-VCA IgM antibody is present in the specimen. The Lite Reagent contains monoclonal anti-human IgM labeled with acridinium ester and is used to detect EBV-VCA IgM in the specimen.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ADVIA Centaur EBV-VCA IgM

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the reported performance metrics. For a diagnostic device intended to aid in the diagnosis of infection, common acceptance criteria would include achieving certain levels of Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a reference method, especially in relevant clinical populations (e.g., primary acute infection). Precision and reproducibility are also key acceptance criteria for laboratory assays.

2. Sample Size and Data Provenance:

• Clinical Study Test Set:
  • Total Study Population: 1428 leftover samples (Population 1) + 202 samples with known EBV VCA IgM positive result (Population 2). Total = 1630 samples.
    • Population 1: Collected over a contiguous time period from individuals for whom an EBV test was ordered.
    • Population 2: Samples with a known EBV VCA IgM positive result.
  • Pediatric Population: 479 samples (from Population 1) + 155 samples (from Population 2). Total = 634 samples.
  • Data Provenance: The document states "leftover samples were collected over a contiguous time period" and "multisite clinical study," suggesting diverse geographical sources and a real-world setting. It does not explicitly state country of origin but implies a clinical laboratory setting. The samples are retrospective (leftover samples).

3. Number of Experts and Qualifications for Ground Truth:

• This information is not explicitly provided in the document. The comparison is made against an "FDA-cleared EBV VCA IgM reference assay."
• For equivocal reference assay results, the ground truth was "resolved by 2 other comparative assays." This implies an algorithmic or rule-based resolution rather than human expert consensus for these specific cases.

4. Adjudication Method for the Test Set:

• The document states: "Equivocal reference assay results were resolved by 2 other comparative assays." This indicates a form of algorithmic or rule-based adjudication rather than a human expert consensus method (like 2+1 or 3+1). If the two additional comparative assays agreed, that would constitute a form of resolution. If they disagreed, the method for final resolution is not detailed.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay, not an imaging device or a device requiring human interpretation as part of its primary function where reader performance would be a direct outcome. The performance is assessed by comparing the assay's output to a reference method, not by how human readers improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

• Yes, a standalone performance study was done. The entire clinical and analytical performance evaluation describes the ADVIA Centaur EBV-VCA IgM assay's performance independently (as an algorithm/assay) against a reference standard or for its inherent analytical characteristics (precision, reproducibility). There is no "human-in-the-loop" component described for the assay's function itself; it is an automated immunoassay.

7. Type of Ground Truth Used:

• The primary ground truth was established by an "FDA-cleared EBV VCA IgM reference assay."
• For cases where the reference assay was equivocal, "2 other comparative assays" were used for resolution.
• For defining "primary acute infection," the presence of "either EBV IgM or heterophile antibodies, and the absence of EBNA IgG" was used – this relies on a combination of other serological markers/tests.

8. Sample Size for the Training Set:

• The document does not provide information on the training set for the ADVIA Centaur EBV-VCA IgM assay. As a chemical immunoassay, its "training" involves the development and optimization of its chemical components, reagents, and detection parameters, using internal development studies that are typically not detailed as "training sets" in the same way as machine learning models. The reported studies are for validation/testing.

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

• As the document does not mention a "training set" in the context of machine learning, this question is not applicable/not addressed by the provided text. The development process for such an immunoassay typically involves extensive R&D, analytical characterization, and optimization using well-characterized samples, but this is distinct from establishing ground truth for a machine learning training dataset.

Ask a specific question about this device

The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

For in vitro diagnostic use.

The Lp (a) Calibrators are a set of 5 levels required to establish the calibration curve of the Quantia Lipoprotein (a) reagents (K050487) for the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma using immunoturbidimetry technology on the ARCHITECT c Systems.

The Lp (a) Control are a set of 2 levels used to monitor the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma with the Quantia Lipoprotein (a) reagents (K050487) using immunoturbidimetry technology on the ARCHITECT c Systems.

Quantia Lp(a) Reagent included two equivalent reagents presentation that only differ on the geographic distribution zone:

• Reference 7K00-40 Quantia Lp(a) Reagent (US) -
• Reference 7K00-01 Quantia Lp(a) Reagent (EX-US)

Both Quantia Lp(a) Reagents reference will use the Lp(a) Calibrators and Lp(a) Control products.

The human serum used in the Lp(a) Calibrators and Lp(a) Control is nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV using FDA approved methods.

Here's a breakdown of the acceptance criteria and study information for the Lp(a) Calibrators and Lp(a) Control, based on the provided 510(k) summary:

Description of Device

The Lp(a) Calibrators and Lp(a) Control are for in vitro diagnostic use to assist in measuring Lipoprotein (a) concentration in human serum or plasma.

Device Components:

• Lp(a) Calibrators: A set of 5 levels used to establish the calibration curve for the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.
• Lp(a) Control: A set of 2 levels (Control I and Control II) used to monitor the quantitative measurement of Lipoprotein (a) concentration with the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size for Test Set:
     • Calibrator Value Assignment: 30 replicates for each level of the new manufactured calibrator lot, the Master lot, and the previously released calibrator lot.
     • Control Value Assignment: Data generated from multiple runs (specific number not provided) on the ARCHITECT c8000 System.
   • Data Provenance: Not explicitly stated, but the applicant's address is in Llica d'Amunt, Barcelona, Spain, suggesting the studies were conducted there. The studies appear to be prospective for product development and validation.

2. 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 is a clinical chemistry device, not an imaging device that relies on expert interpretation. The ground truth (assigned values for calibrators and controls) is established through analytical methods and comparisons to a Master lot, not by human experts in the traditional sense of image adjudication.

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

   • Not applicable. This is not an imaging or diagnostic device that requires human adjudication of results. The "adjudication" is based on statistical analysis of quantitative measurements against established criteria and comparison to a Master lot.

4. 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 a calibrator and control material for an automated clinical chemistry analyzer. It does not involve human readers or AI assistance in interpretation.

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

   • The device (calibrators and controls) operates in conjunction with the Quantia Lp(a) reagents on the ARCHITECT c Systems. The performance described is essentially the "standalone" analytical performance of the calibrators and controls to provide accurate values. There's no human-in-the-loop component for the calibrators/controls themselves; they are reagents used by the automated system.

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

   • The ground truth for the calibrators and controls is established via assigned values. These assigned values are determined:
     • For calibrators: By comparing to an "existing Master lot" of calibrators.
     • For controls: By repeated measurements on the ARCHITECT c8000 System using the Quantia Lp(a) Reagent, generating a mean value and acceptance ranges.
     • Traceability to a commercial EIA (Enzyme Immunoassay) method was used for in-house reference material establishment, as no international reference material exists for Lp(a) in mg/dL.

7. The sample size for the training set

   • Not explicitly defined as a "training set" in the context of an AI/ML device. For value assignment and stability studies:
     • Value Assignment Test: 30 replicates were used for each calibrator level.
     • Stability Studies: Involved comparing results over time to assigned values. The number of samples for the initial assignment and subsequent stability checks is not specified in detail beyond the 30 replicates for value assignment.

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

   • As noted above, this device doesn't have a "training set" in the AI/ML sense. The "ground truth" (assigned values for calibrators and controls) was established through:
     • Comparison to a Master lot for calibrators.
     • Multiple runs on the ARCHITECT c8000 System for controls to calculate their mean values and acceptance ranges.
     • In-house reference materials were value-assigned using a commercial EIA method due to the lack of an international reference standard for Lp(a) in mg/dL.

Ask a specific question about this device

The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT i Vancomycin assay is a device for the quantitative measurement of vancomycin in human serum or plasma. The device is a chemiluminescent microparticle immunoassay (CMIA) for in vitro diagnostic use, intended to aid in the diagnosis and treatment of vancomycin overdose and in monitoring its levels to ensure appropriate therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision: The document states that "Vancomycin samples were tested for precision." It does not specify the exact sample size.
• Recovery: "Serum samples were spiked with vancomycin at concentrations across the assay range." The exact number of samples is not provided.
• Interferences: "Serum specimens with vancomycin levels from 4.4 to 48.8 µg/mL were supplemented with the following potentially interfering compounds." The exact number of specimens or replicates is not provided.
• Linearity: "Samples were tested to demonstrate linearity." The exact number of samples is not provided.
• Sensitivity: "In this study," no specific sample size is mentioned.
• Matrix Comparison: Specific number of samples or details on how many of each type of matrix were tested are not provided.
• Specificity: Specific numbers of samples for each compound tested are not provided.
• Method Comparison: 107 observations were used for the method comparison study between the new and predicate devices.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of in vitro diagnostic device testing for regulatory submission, it is typically conducted prospectively at controlled laboratory sites.

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

This type of device (in vitro diagnostic for quantitative measurement) does not typically rely on human expert interpretation to establish ground truth for performance studies like precision, recovery, linearity, and interference. Instead, the "ground truth" for these studies is established through:

• Known concentrations: For studies like recovery and linearity, samples are spiked with known, precise concentrations of vancomycin or its analogues.
• Reference methods/predicate devices: For method comparison, the "ground truth" for the test samples is derived from measurements by a legally marketed predicate device (ARCHITECT i Vancomycin [LN 1P30-25] in this case) or a traceable reference method.

Therefore, there were no "experts" in the sense of radiologists or pathologists to establish ground truth for this device's performance characteristics.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human readers interpret results and consensus is needed to establish ground truth or resolve discrepancies. Here, the measurements are quantitative chemical analyses performed by an automated system.

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 in vitro diagnostic device for quantitative chemical measurement, not an AI-assisted diagnostic imaging or interpretation system that requires human readers.

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

This entire submission describes the standalone performance of the ARCHITECT i Vancomycin assay (an automated immunoassay system). There is no "human-in-the-loop" component in the direct measurement and quantitation of vancomycin levels. The device itself performs the assay and provides a quantitative result.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using:

• Known concentrations: For precision, recovery, linearity, sensitivity, and specificity studies, samples were prepared with precisely known concentrations of vancomycin or potential interfering/cross-reacting substances.
• Predicate device results: For the method comparison study, the results from the legally marketed predicate ARCHITECT i Vancomycin assay (LN 1P30-25) were used as the comparative "ground truth" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set" in the conventional sense. The device is a traditional immunoassay system with established chemical and optical principles.

However, if "training set" refers to the samples used during the development and optimization phases of the assay before formal validation, that information is not provided in this 510(k) summary. The provided details pertain to the formal validation studies.

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

Not applicable, as there is no "training set" for an AI algorithm described in this submission. For the development and optimization of the immunoassay, ground truth would have been established through a combination of using known calibrators, controls, and potentially reference methods to ensure the assay's chemical and performance characteristics were appropriately tuned.

Ask a specific question about this device

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.

The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 25-hvdroxyvitamin D (25-OH Vitamin D) in human serum and plasma.

The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of 25-hydroxyvitamin D (25-OH Vitamin D) in human serum and plasma.

For in vitro diagnostic use.
Prescription Use

The ARCHITECT 25-OH Vitamin D assay is a delayed one-step immunoassay including a sample pre-treatment for the quantitative determination of vitamin D in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.

Sample and pre-treatment reagent are combined. An aliquot of the pre-treated sample is combined with assay dijuent and paramagnetic anti-vitamin D coated microparticles to create a reaction mixture. Vitamin D present in the sample binds to anti-vitamin D coated microparticles. After incubation a biotinylated vitamin D anti-Biotin acridinium-labeled conjugate complex is added to the reaction mixture and binds to unoccupied binding sites of the anti-vitamin D coated microparticles. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vitamin D in the sample and the RLUs detected by the ARCHITECT i System optics.

The provided 510(k) summary for the ARCHITECT 25-OH Vitamin D assay focuses on demonstrating substantial equivalence to a predicate device rather than establishing comprehensive acceptance criteria with specific thresholds for performance metrics.

Here's an analysis of the available information structured to address your points:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the ARCHITECT 25-OH Vitamin D assay is "substantially equivalent to the LIAISON® 25 OH Vitamin D TOTAL assay in terms of precision, linearity and interferences." However, specific numerical acceptance criteria (e.g., precision CV% < X%, linearity within Y% deviation) are not explicitly defined in this summary. The reported performance is primarily presented as the correlation with the predicate device.

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

The document does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the sample collection).

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

This type of information is not applicable to this submission, as the "ground truth" for evaluating the ARCHITECT 25-OH Vitamin D assay's performance is based on its correlation with a legally marketed predicate device (LIAISON® 25 OH Vitamin D TOTAL), not on expert consensus or interpretation of images/data. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

This is not applicable. As stated above, the evaluation relies on a comparison to a predicate device, not on expert adjudication of a test set.

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 ARCHITECT 25-OH Vitamin D assay is an in vitro diagnostic (IVD) immunoassay for quantitative determination of a biomarker. It is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Yes, the study described is a standalone performance study of the ARCHITECT 25-OH Vitamin D assay. It evaluates the device's analytical performance on its own, comparing its results to a predicate device. There is no "human-in-the-loop" component in the assay's function.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) used for evaluating the ARCHITECT 25-OH Vitamin D assay's performance was the results obtained from the LIAISON® 25 OH Vitamin D TOTAL assay. This represents a comparison to a legally marketed, previously cleared device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For an immunoassay like this, the "training" equivalent would typically involve assay development and optimization using various formulations and reagent concentrations, rather than a distinct "training set" of patient samples in the way an AI algorithm would have. The performance data presented is likely from a validation or testing set.

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

As noted in point 8, a distinct "training set" with established ground truth in the context of an AI algorithm is not directly applicable here. The development and optimization of the immunoassay would have involved internal analytical validation using reference materials and potentially patient samples, with their values determined by established methods or reference assays. However, the document does not detail this process explicitly. The "ground truth" for the performance evaluation described is the predicate device's results.

Ask a specific question about this device

The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.

The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.

For in vitro diagnostic use.

The ARCHITECT iDigoxin assay is a one-step STAT immunoassay for the quantitative measurement of digoxin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antidigoxin coated paramagnetic microparticles, assay diluent, and digoxiqenin acridinium-labeled conjugate are combined to create a reaction mixture. The antidigoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of digoxin in the sample and the RLUs detected by the ARCHITECT i System optics.

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a 510(k) submission for the ARCHITECT iDigoxin assay, claiming substantial equivalence to a predicate device. The primary performance metric reported is based on this equivalence.

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size used for the clinical performance study or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "non-clinical performance data" and "clinical performance data" without specifying details about the clinical study itself.

3. Number and Qualifications of Experts for Ground Truth:

The document does not mention the use of experts to establish ground truth for the test set. For in vitro diagnostic devices like the ARCHITECT iDigoxin, the ground truth is typically clinical samples analyzed by a reference method or the predicate device itself, rather than expert interpretation of images or clinical scenarios.

4. Adjudication Method:

The document does not mention any adjudication method, as it doesn't describe a scenario where expert consensus or conflict resolution would be required. The clinical performance is assessed by comparing results to a predicate device.

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

An MRMC study was not performed or described. This type of study is typically relevant for interpretative devices where human readers assess cases (e.g., radiology images). The ARCHITECT iDigoxin is a quantitative immunoassay, not an interpretative device, so an MRMC study is not applicable. Therefore, there is no effect size reported for human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The device itself is a standalone algorithm (an immunoassay system). The "performance" section describes the device's ability to measure digoxin levels in comparison to a predicate device. So, the clinical performance reported (Pearson correlation coefficient of 0.993) is the standalone performance of the ARCHITECT iDigoxin assay against the predicate device.

7. Type of Ground Truth Used:

For the clinical performance study, the "ground truth" was established by the measurements obtained from the legally marketed predicate device, Aeroset Multigent Digoxin. The ARCHITECT iDigoxin's readings were correlated with the readings from this established device.

8. Sample Size for Training Set:

The document does not explicitly state the sample size used for any training set. For an immunoassay, "training" might involve calibrating the system and optimizing reagents, but details on sample sizes for these internal processes are not provided in this regulatory summary.

9. How Ground Truth for Training Set was Established:

The document does not explicitly describe how ground truth for a training set was established. Immunoassays are typically "trained" or calibrated using a series of calibrator materials with known concentrations. The ARCHITECT iDigoxin Calibrators (A-F) are mentioned, which would be used for the calibration process. The ground truth for these calibrators would be established through a traceable reference method by the manufacturer.

Ask a specific question about this device

The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

For in vitro diagnostic use.

Not Found

The provided document is a 510(k) summary for the ARCHITECT C-Peptide Calibrators and Controls. It describes the intended use and states substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document is a regulatory approval notification, not a performance study report.

Ask a specific question about this device

The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.

For in vitro diagnostic use.

The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the clinical performance comparison, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only states that a "Summary of Clinical Performance" demonstrated "substantially equivalent performance" with a correlation coefficient of 0.996.

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

Not applicable. This is an in vitro diagnostic device for quantitative measurement of vancomycin in human serum or plasma. Ground truth is established by a reference method (the predicate device) or by the inherent accuracy of the chemical measurement itself, rather than by human expert consensus or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic interpretation tasks where human readers are involved. For an in vitro diagnostic device like this, the comparison is between the new device and a predicate device in terms of analytical performance.

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

Yes, the study described is a standalone performance assessment of the ARCHITECT iVancomycin assay. The device itself performs the quantitative measurement without human interpretation as part of its core function, although human operators are involved in running the assay. The comparison directly evaluates the device's analytical output against that of a predicate device.

7. The Type of Ground Truth Used

The ground truth or reference standard for evaluating the ARCHITECT iVancomycin assay's performance was the AxSYM Vancomycin II assay, which is the legally marketed predicate device. The clinical performance summary indicates a direct comparison of results between the new device and the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a system involves the development and optimization of the reagent formulations, reaction conditions, and calibration procedures, which are determined during the device development phase, not through a "training set" of patient data as in machine learning.

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

Not applicable. See point 8.

Ask a specific question about this device

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (K050613).

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Quantia Beta-2-Microglobulin reagent was already 510(k) cleared as Quantia Beta-2-Microglobulin for its use with serum and EDTA plasma (K050613). A new submission for the Quantia Beta-2-Microglobulin reagent has been prepared as it is intended to also claim urine as a sample. The kit Quantia Beta-2-Microglobulin already cleared, contained Buffer and Latex Reagent. The Calibrators were already cleared in the submission K050613. There have also been added two different levels of controls in a separate kit. The controls are supplied by Bio-Rad (K851202/A1) and the values are assigned at Biokit S.A. This test with Biokit labeling was cleared K050596.

Here's an analysis of the provided text regarding the Quantia Beta-2 Microglobulin device, presented according to your requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the Quantia Beta-2 Microglobulin doesn't explicitly state "acceptance criteria" in a typical numerical pass/fail format. Instead, it demonstrates substantial equivalence to a predicate device through various performance characteristics. The table below outlines these performance metrics and the reported results. The implication is that these results were considered acceptable for demonstrating substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 110 urine samples were used for the method comparison study.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

• This information is not provided in the document. The study involves a method comparison against a predicate device, which itself is an already cleared diagnostic for measuring a biochemical marker, Beta-2 Microglobulin. The "ground truth" here is the measurement by the predicate device, not typically established by human experts in this context.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Adjudication is typically associated with studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies, such as in image analysis or clinical diagnosis studies. For a quantitative assay comparing against a predicate, discrepancies are resolved through analytical comparison statistics.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) where the AI assists the human, and the effect size would relate to the improvement in human performance with AI assistance. The Quantia Beta-2 Microglobulin is an in-vitro diagnostic assay for quantitative biochemical measurement, not an AI-assisted interpretation tool for human readers.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence, the described performance studies are for the standalone performance of the Quantia Beta-2 Microglobulin assay. It measures the Beta-2 Microglobulin concentration without human intervention influencing the measurement result itself (though a human performs the test). The results for method comparison, precision, linear range, and interference are all measures of the device's standalone analytical performance.

7. Type of Ground Truth Used

• The "ground truth" used for the method comparison study was the measurement result obtained from the predicate device, the IL Test Beta-2-Microglobulin, on the same samples. For precision, linear range, and interference studies, the ground truth is derived from established analytical methods and reference values.

8. Sample Size for the Training Set

• This information is not provided or applicable in the traditional sense of a "training set" for machine learning algorithms. The Quantia Beta-2 Microglobulin is a reagent-based immunoturbidimetric assay, not a machine learning model that requires a labeled training set in the same way. Its development would involve analytical characterization and optimization using various samples, but not a distinct "training set" as understood in AI/ML contexts.

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

• As noted above, a "training set" in the context of machine learning is not directly applicable here. The development and optimization of such a diagnostic assay would typically involve using samples with known analyte concentrations (established through reference methods or other validated assays) to calibrate the assay, determine reaction kinetics, and establish performance characteristics. This is part of the assay's analytical development process rather than establishing a "ground truth" for a training set in an AI/ML context.

Ask a specific question about this device

The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders.

The ARCHITECT Intact PTH Calibrators are for the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

For in vitro diagnostic use.

The ARCHITECT Intact PTH assay is a two-step sandwich immunoassay for the quantitative determination of intact PTH in human serum and plasma using CM1A technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-PTH coated paramagnetic microparticles are combined. Intact PTH present in the sample binds to anti-PTH coated microparticles. After washing, the anti-PTH acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of intact PTH in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of intact PTH in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT Intact PTH calibration.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, accuracy thresholds). Instead, the primary acceptance criterion appears to be substantial equivalence to the predicate device, the ROCHE® Elecsys Parathyroid Hormone Test System (K992680). The performance is reported in terms of correlation coefficients.

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

• Sample Size: The document does not specify the exact sample size used for the performance comparison studies (non-clinical or clinical). It only states that the ARCHITECT Intact PTH assay 'demonstrated substantially equivalent performance to the Roche Elecsys PTH'.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the given text. The studies appear to be comparative performance studies against a predicate device, which itself acts as the "ground truth" for comparison, rather than requiring independent expert-established ground truth. This is common for IVD devices where the performance is benchmarked against an existing, approved method.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the study design is a comparison to a predicate device, a complex adjudication method for establishing ground truth is likely not applicable in the same way it would be for, for example, an imaging AI device interpreting images.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: This type of study and effect size is not applicable as this is an in vitro diagnostic (IVD) immunoassay device, not an AI device designed to assist human readers (e.g., radiologists). The device itself performs the measurement.

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

Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT Intact PTH assay. The device measures intact PTH quantitatively from human serum and plasma directly. There is no "human-in-the-loop" component in the assay's primary function of determining the hormone concentration. The output is a numerical value, not an interpretation requiring human input for its primary function.

7. The Type of Ground Truth Used

The "ground truth" used for these studies was the performance of the legally marketed predicate device: The ROCHE® Elecsys Parathyroid Hormone Test System (K992680). The ARCHITECT Intact PTH assay's results were compared directly against those produced by the Roche Elecsys PTH system.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is an immunoassay, not a machine learning or AI algorithm that typically has a separate "training set." The development of the assay (e.g., optimizing reagents, establishing calibration curves) is a different process than "training" an AI model.

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

This information is not provided and is generally not applicable in the context of a traditional immunoassay. For such devices, "ground truth" typically refers to the results obtained from a reference method or validated predicate device during performance evaluation, not a "training set" ground truth in the AI sense. The "ground truth" for calibrators and controls would have been established through a robust process of analytical characterization and traceability to higher-order reference materials, but the document does not detail this.

Ask a specific question about this device