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The ADVIA Centaur® Erythropoietin (EPO) assay is for in the quantitative measurement of exythropoitin in pediatric and adult human serum or plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Measurement of erythropoietin is used as an aid in the diagnosis of anemias and polycythemias.

The ADVIA Centaur EPO assay is a fully automated, one-step sandwich immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium-ester-labeled monoclonal mouse anti-EPO antibody in the Lite Reagent. The Solid Phase consists of mouse anti-EPO monoclonal antibody-coated paramagnetic microparticles.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the ADVIA Centaur Erythropoietin (EPO) assay:

1. Table of Acceptance Criteria and Reported Device Performance

This table compiles information primarily from the "Summary of Non-Clinical Performance" and "Summary of Clinical Performance" sections.

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

• Linearity: Not specified, but involved three high EPO samples mixed with low EPO human serum.
• Dilution Recovery: 10 samples (containing high EPO levels: 618.63-986.07 mIU/mL).
• Detection Capability (LoD): 323 determinations using 10 low-level samples.
• Cross-reactivity: Not explicitly stated as a "sample size," but involved numerous cross-reactants (e.g., various plasma proteins, epoetin alfa, darbepoetin alfa).
• Interference: Not explicitly stated as a specific "sample size" for each interferent, but involved various substances tested at different concentrations.
• Precision: 7 pooled serum samples. For each sample, there were 80 observations (replicates of 2, in 2 runs/day, over 20 days).
• Specimen Collection Comparison: 65 samples (serum EPO values ranging from 4.39 - 707.81 mIU/mL).
• Method Comparison:
  • Study 1: 216 human serum samples (range: 3.29 – 691.60 mIU/mL).
  • Study 2: 100 human serum samples from US population (range: 4.45 - 407.74 mIU/mL).
  • Study 3 (Multi-site): 327 human serum samples (range: 3.55 - 596.81 mIU/mL), with ≥ 100 samples per site.
• Expected Values (Adult): 251 apparently healthy subjects (128 males, 123 females), older than 21 years of age.
• Expected Values (Pediatric): 266 apparently healthy children (2 to

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The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measuremt of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

The ADVIA Centaur CALCT Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CALCT Lite Reagent and Solid Phase reagent, and one set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each). ADVIA Centaur CALCT Calibrator Assigned Value Card and barcode labels and ADVIA Centaur CALCT Master Curve Card are also included in the kit. The ADVIA Centaur CALCT assay is a fully automated, two-step immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium- ester-labeled recombinant antibody as the Lite Reagent. The Solid phase consists of anti-calcitonin mouse monoclonal antibody-coated paramagnetic microparticles.

Here's a summary of the acceptance criteria and study information for the ADVIA Centaur® Calcitonin (CALCT) assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Linearity: Not explicitly stated as a "test set" in the context of patients, but rather an analytical study using two samples containing high levels of calcitonin mixed with analyte-free human serum. The number of measurements performed for linearity or dilution recovery is not explicitly stated.
• Dilution Recovery: Fourteen samples containing high levels of calcitonin.
• Detection Capability (LoD): 125 determinations using 6 low-level samples.
• Precision: Five pooled serum samples, tested in replicates of 2, in 2 runs per day, over 20 days, yielding 80 observations per sample (400 total observations for the 5 samples).
• Cross-reactivity: Tested with individual cross-reactants. Number of samples per reactant not specified.
• Interference: Tested using two levels of calcitonin with various interfering substances. Number of samples not specified. For biotin, samples containing different calcitonin levels were tested.
• Specimen Collection Comparison: 60 samples.
• Method Comparison: 97 human serum samples.
• Expected Values (Reference Intervals): 240 apparently healthy subjects (120 males, 120 females), age range 22-79 years.

Data Provenance: The document generally describes these as studies performed by the manufacturer, Axis-Shield Diagnostics Limited, in support of their 510(k) submission. It does not provide specific country of origin for the patient/human serum samples, nor explicitly state if they are retrospective or prospective. However, based on the nature of these analytical and clinical validation studies for a diagnostic device, they are typically conducted prospectively to evaluate the device's performance.

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

This is an in vitro diagnostic (IVD) device designed for quantitative measurement of calcitonin. The "ground truth" for such devices is established through laboratory methods and standards (e.g., traceable reference materials, expert consensus on method accuracy, or clinical outcomes for reference ranges).

• For analytical performance (linearity, detection capability, precision, etc.): Ground truth is established by the analytical reference methods, international standards (e.g., WHO 2nd IRP 89/620), and carefully prepared samples with known concentrations. No "experts" in the sense of clinicians or radiologists are typically involved in establishing this type of ground truth.
• For expected values/reference intervals: While derived from human subjects, the calculation of reference intervals is a statistical process (97.5th percentiles) rather than an "expert" adjudication of individual cases. The "apparently healthy subjects" serve as the basis for this ground truth.

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

Not applicable. This is not an image-based diagnostic or clinical decision support AI where human experts adjudicate classifications. The device measures a biomarker quantitatively.

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 assay, not an AI-assisted diagnostic device for human readers/clinicians reading images or other complex data.

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

Yes, the studies described (linearity, precision, detection capability, interference, method comparison) are all standalone performance evaluations of the ADVIA Centaur CALCT assay. The device provides a quantitative measurement of calcitonin from a human serum sample without human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the immunoassay's measurement and calculation protocols.

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

• Analytical Performance: Primarily analytical standards (e.g., CLSI protocols EP06-A, EP17-A2, EP05-A3, EP07-A2), international reference materials (WHO 2nd IRP 89/620), and known concentrations in spiked or diluted samples.
• Expected Values (Reference Intervals): Derived from samples from a population of apparently healthy subjects, with the normal range defined statistically (97.5th percentiles).
• Method Comparison: Comparison against a "comparable method" (the Roche Elecsys/Cobas® Calcitonin assay, which is the predicate device), where the predicate serves as the comparative "ground truth" for demonstrating equivalence.

8. The sample size for the training set:

Not explicitly stated. For an IVD such as this, the development ("training") of the assay involves various stages of optimization and formulation. The provided document focuses on the validation or test data used to demonstrate performance for regulatory purposes. The term "training set" is more commonly used in machine learning. However, if interpreted as samples used during the development phase to establish assay parameters, that information is not detailed in this summary.

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

Not explicitly stated. Similar to point 8, this refers to assay development. Ground truth during development would typically involve using highly characterized samples, reference materials, and comparing results to established methods to refine the assay's chemical and procedural parameters.

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The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.

Quality Control:
The ADVIA Centaur® Anti-CCP IgG (aCCP) quality control material is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur aCCP assay using the ADVIA Centaur systems.

Master Curve Material (MCM):
The ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur aCCP assay.

The ADVIA Centaur aCCP assay is a fully automated, two-step immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-human lgG as the Lite Reagent. The Solid Phase consists of biotinylated CCP coupled to streptavidin which is then coated onto magnetic latex microparticles.

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

Device Name: ADVIA Centaur® Anti-CCP IgG (aCCP) Assay

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, quantitative table derived from a pre-defined standard (like a predicate device's performance). Instead, it compares the performance of the new device (ADVIA Centaur aCCP assay) to a predicate device (ARCHITECT Anti-CCP Assay) for several characteristics and implies that similar performance constitutes meeting the criteria for substantial equivalence. I will reconstruct a table showing the implied acceptance criteria (based on the predicate's performance or general expectations for such an assay) and the reported performance.

2. Sample Sizes and Data Provenance:

• Test Set (Clinical Performance):
  • Method Comparison Study: 253 samples (143 confirmed positive for RA, and 110 samples where other auto-antibodies may be present). Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective), but it is a clinical study.
  • Clinical Sensitivity and Specificity Study: 767 patient samples.
    • 307 confirmed-positive RA subjects.
    • 460 non-RA subjects with potentially cross-reacting conditions (22 subgroups).
    • Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective).
• Training Set: Not explicitly mentioned for this type of in vitro diagnostic assay. Immunoassays are generally calibrated and validated, not "trained" in the machine learning sense. The "training" in this context would likely refer to the development and optimization of the assay reagents and parameters.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• For RA Confirmation: "307 confirmed-positive RA subjects that were classified according to the American College of Rheumatology criteria." This implies expert clinical diagnosis based on established criteria, but the specific number and qualifications of individuals making these diagnoses are not provided.
• For Non-RA Subjects: "22 subgroups of non-RA subjects (n=460) with potentially cross-reacting conditions." This also implies clinical diagnosis by experts, but details are not provided.
• For Autoantibody Presence (Method Comparison): "110 samples where other auto-antibodies may be present." This suggests expert determination of autoantibody status, but details are not given.

4. Adjudication Method for the Test Set:

Not applicable or explicitly stated as this is an immunoassay, not an imaging device requiring expert adjudication of reader interpretations. The ground truth for clinical sensitivity and specificity is based on clinical diagnosis (American College of Rheumatology criteria for RA).

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging devices or AI tools that assist human readers in interpretation. The ADVIA Centaur anti-CCP IgG assay is a standalone diagnostic laboratory test.

6. Standalone Performance:

Yes, standalone performance was done. The entire document describes the standalone performance of the ADVIA Centaur aCCP assay in various analytical and clinical studies (linearity, dilution linearity, detection capability, high dose hook, cross-reactivity, interference, precision, specimen collection comparison, clinical concordance with a predicate, and clinical sensitivity/specificity against clinical diagnosis). The results presented are solely the performance of the algorithm/assay without human intervention in the result determination.

7. Type of Ground Truth Used:

• Analytical Performance: Based on reference materials, spiked samples with known concentrations, or established analytical methods.
• Clinical Performance (Sensitivity/Specificity):
  • RA Diagnosis: American College of Rheumatology criteria (clinical diagnosis) for RA.
  • Non-RA Status: Clinical diagnosis of various conditions (22 subgroups).
• Method Comparison: The predicate device (ARCHITECT Anti-CCP Assay) results were used as a reference point for agreement.

8. Sample Size for the Training Set:

Not applicable in the machine learning sense. For an immunoassay, "training" is typically assay development, which involves optimizing reagents and parameters. The document doesn't specify sample sizes used during the development phase.

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

Not applicable. For an immunoassay, ground truth during development would involve well-characterized samples (e.g., confirmed positive/negative for CCP antibodies, known concentrations) to optimize the assay's performance characteristics. Specific details on this are not provided in the summary.

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The ADVIA Centaur® Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

The ADVIA Centaur® Active-B12 (AB12) quality control is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur AB12 (Holotranscobalamin) assay using the ADVIA Centaur systems.

The ADVIA Centaur® Active-B12 (AB12) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur AB12 (Holotranscobalamin) assay using the ADVIA Centaur systems.

The ADVIA Centaur AB12 assay is a fully automated, two-step direct immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled antitranscobalamin antibody as the Lite Reagent. The Solid Phase consists of biotinylated antiholotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles.

This document describes the ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay, a device for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum to aid in the diagnosis and treatment of vitamin B12 deficiency.

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

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

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

• Linearity: The number of samples used is not explicitly stated, but it involved "Two samples containing high levels of active-B12" mixed with "a pool of artificial serum matrix."
• Dilution Linearity: Five samples were used.
• Detection Capability (LoB, LoD, LoQ): The raw sample sizes for these determinations are not specified but are described as being determined according to CLSI Document EP17-A2, which typically involves multiple replicates and measurements.
• High Dose Hook: Patient samples with "active-B12 levels as high as 1867.80 pmol/L" were tested. The exact number of samples is not stated.
• Cross-reactivity: Populations evaluated included "other B12 proteins apotranscobalamin and haptocorrin" at two different concentrations each. The number of samples per concentration is not stated.
• Interference: The number of unique samples or runs for each interfering substance is not explicitly stated.
• Precision: Five serum precision panel members were used. Each sample was tested in replicates of 2 in two runs per day over 20 days, resulting in 80 observations per sample for each reagent lot.
• Method Comparison: 104 serum samples were used.
• Expected Values (Reference Range): 241 apparently healthy males (n = 103) and females (n = 138) were used. The age range was 21 - 67 years.

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that the device is manufactured by Axis-Shield Diagnostics Ltd. in Scotland, UK. The reference range study involved "apparently healthy males and females," suggesting prospective collection for that specific study.

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 device is an in-vitro diagnostic assay for quantitative measurement of holotranscobalamin. The "ground truth" for such assays is typically established by established reference methods, calibrated standards, or the concentration values determined by a legally marketed predicate device. Experts are not directly involved in establishing "ground truth" for individual test results in the same way they would be for image interpretation.

• For method comparison, the "ground truth" reference values were obtained from the ARCHITECT Active-B12 (Holotranscobalamin) assay (K112443), which is the legally marketed predicate device.
• For reference range establishment, the "ground truth" is derived from the statistical analysis of results from a healthy population, following established protocols (EP28-A3c).

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

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The performance is based on quantitative measurements.

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, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, the studies presented are standalone performance evaluations of the ADVIA Centaur Active-B12 assay. The performance characteristics (linearity, precision, detection capability, interference, cross-reactivity, method comparison) are intrinsic to the device and do not involve human intervention in the interpretive output generation. The assay quantitatively measures holotranscobalamin levels.

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

The ground truth used depends on the specific performance characteristic:

• Assay values for clinical samples: The ARCHITECT Active-B12 (Holotranscobalamin) assay (CMIA) was used as the comparator or "reference" for method comparison studies.
• Known concentrations: For studies like linearity, dilution linearity, detection capability, high dose hook, cross-reactivity, and interference, the "ground truth" is based on known spiked concentrations of substances or defined samples with expected values (e.g., precision panel members with established active-B12 concentrations).
• Population statistics: For expected values (reference range), the "ground truth" is derived from statistical analysis of a healthy reference population, following CLSI guidelines.

8. The sample size for the training set:

Not applicable. This device is an in-vitro diagnostic assay, not a machine learning or AI model that requires a distinct training set in the conventional sense. The "training" or development of such assays involves reagent formulation, optimization, and calibration based on known standards and samples, but not a "training set" like that used for algorithms.

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

Not applicable. As explained in point 8, there isn't a "training set" for an in-vitro diagnostic assay in the same way there is for an AI algorithm. The assay is developed and optimized using known standards and calibrated samples, where the "ground truth" for these is established through highly accurate reference methods or certified reference materials. The calibration of the device itself relies on "Master Curve Material" (MCM) with established values.

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