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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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Elecsys Calcitonin Immunoassay:
The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.

Elecsys Calcitonin CalSet:
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers.

Elecsys Calcitonin CalCheck 5:
The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analvzers.

Elecsys PreciControl Varia:
The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

The Calcitonin Assay employs monoclonal antibodies specifically directed against hCT. The antibodies labeled with a ruthenium complex and biotin, respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.

This document describes the specifications and comparative characteristics of the Elecsys Calcitonin Immunoassay and its associated calibrators and quality controls against predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance (Elecsys Calcitonin Immunoassay vs. Predicate Device)

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The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)

I am sorry, but the provided text does not contain detailed information about acceptance criteria, study methodologies, or performance data for the Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version).

The document is an FDA 510(k) clearance letter, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device. It states the indications for use but does not delve into the specifics of performance studies, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your detailed questions about acceptance criteria and how they were met.

Therefore, I cannot provide the requested table or the specific details regarding the studies performed.

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The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, Cl- (or Ca++), Glu and Lac in serum and heparinized plasma.

Not Found

The provided text is a 510(k) premarket notification approval letter for the "Stat Profile pHOx Plus L. Analyzer". This document indicates the device has been found substantially equivalent to a predicate device for its stated indications for use.

However, this letter does NOT contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on the regulatory approval process, confirming that the device can be marketed in the US. It does not include the technical study reports that would detail the performance data and the methods used to generate that data.

To answer your questions, one would typically need access to:

• The actual 510(k) submission document, specifically the sections dealing with performance testing.
• Validation reports from Nova Biomedical for the Stat Profile pHOx Plus L. Analyzer.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner you've requested. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Multi-reader multi-case comparative effectiveness study information.
6. Standalone performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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IMMULITE/IMMULITE 1000 Calcitonin: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
IMMULITE 2000 Calcitonin: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin are solid-phase, chemiluminescent enzyme immunoassays for use with their respective IMMULITE/IMMULITE 1000 and IMMULITE 2000 Automated Analyzers.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE®/IMMULITE® 1000 Calcitonin and IMMULITE® 2000 Calcitonin devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "substantial equivalence" is implicitly defined by the demonstration of comparable performance to the predicate device, Nichols Advantage™ Calcitonin. The key performance metrics presented are related to inter-assay agreement as measured by linear regression and correlation.

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

• IMMULITE/IMMULITE 1000 Calcitonin:
  • Sample Size: 53 patient samples
  • Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "patient samples," implying human origin. It does not specify if the data was retrospective or prospective.
• IMMULITE 2000 Calcitonin:
  • Sample Size: 67 patient samples
  • Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "patient samples," implying human origin. It does not specify if the data was retrospective or prospective.

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

Not applicable. This study is a method comparison study between a new device and a predicate device (Nichols Advantage™ Calcitonin), not a study relying on expert-established ground truth for diagnostic classifications. The "ground truth" for each sample is the calcitonin concentration as measured by the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as this is a method comparison study and not a study involving human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic assay, comparing its quantitative results against a legally marketed predicate device. It does not involve human readers interpreting cases or AI assistance.

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

Yes, this is essentially a standalone performance study. The IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin assays are in vitro diagnostic devices that directly measure a biomarker concentration. Their performance is evaluated based on the quantitative output of the automated analyzer, without human interpretation in the loop impacting the measurement itself. The comparison is directly between the new assay's output and the predicate assay's output.

7. The Type of Ground Truth Used

The "ground truth" for the comparison is the quantitative calcitonin measurement obtained from the predicate device, the Nichols Advantage™ Calcitonin assay. This is a form of comparative ground truth against an established and legally marketed assay.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" in the context of developing the IMMULITE Calcitonin assays. For in vitro diagnostic devices like these, method comparison studies are typically performed after the assay's development and optimization, so there isn't a "training set" in the machine learning sense. The samples used are for direct comparison/validation.

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

Not applicable, as there is no explicitly mentioned "training set" in the context of this submission. The assays are developed based on chemical and immunological principles, and their performance is then validated against established methods.

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