Search Results

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.

Ask a specific question about this device

The IMMULITE® 2000 Calcitonin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Calcitonin assay on the IMMULITE 2000 systems.

The IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE PAP assay on the IMMULITE 2000 systems.

The IMMULITE® 2000 Calcitonin Calibration Verification Material (CVM) contains one set of four vials each 3mL after reconstitution. CVM1 contains bovine protein buffer matrix with preservatives and CVM2, CVM3, and CVM4 contain calcitonin in bovine protein buffer matrix with preservative.

The IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (CVM) contains one set of four vials, 2mL each after reconstitution. CVM1 contains a bovine protein/buffer with 0.27% sodium azide and preservative. CVM2, CVM3, and CVM4 contain human prostatic acid phosphatase in a bovine protein/buffer matrix with 0.27% sodium azide and preservative.

This document describes two distinct calibration verification materials: IMMULITE® 2000 Calcitonin Calibration Verification Material and IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material. I will address each product separately as the acceptance criteria and supporting studies differ.

IMMULITE® 2000 Calcitonin Calibration Verification Material

This section describes the acceptance criteria and study for the IMMULITE® 2000 Calcitonin Calibration Verification Material (CVM).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the stability study supports the stated claims, which implies the acceptance criteria were met, but does not provide specific performance data points for a direct, side-by-side comparison in the summary.

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

• Test Set Sample Size for Stability:
  • Shelf-life stability: "The CVM study protocols are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) at the time points shown in Table 2."
    • Time points: Day 0, 48 months, 54 months, 60 months for all 4 CVM levels.
    • Therefore, at least 2 replicates x 4 levels x 4 time points = 32 measurements.
  • Open Component (in-use) stability: "CVM lot 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions." No specific number of replicates or runs for this part is explicitly stated beyond "results were determined from a 2-point adjustment."
• Test Set Sample Size for Expected Values/Target Values/Reference Range: "Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run, 3 different reagent kit lots and 8 IMMULITE 2000 systems."
• Data Provenance: The document does not explicitly state the country of origin. It is a submission to the FDA (USA). The study is prospective in nature as it is a stability study tracking performance over time.

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

• Not applicable. This device is a calibration verification material for an in vitro diagnostic assay, not an imaging or diagnostic AI requiring expert human interpretation for ground truth. The "ground truth" (assigned dose values) for the CVMs is established through a scientific process involving reference calibrators and measurement procedures.

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

• Not applicable. This is not a study requiring human adjudication. The results are quantitative measurements against predefined criteria.

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

• Not applicable. This is not an AI/imaging device.

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

• This is an in vitro diagnostic calibration verification material. Its performance is evaluated intrinsically through laboratory testing, essentially a "standalone" evaluation of the material's stability and value assignment, but not in the context of an AI algorithm.

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

• The ground truth for the CVM is its "assigned dose" values. These values are established through:
  • Traceability to WHO 2nd IRP 89/620.
  • Manufacture using qualified materials and measurement procedures.
  • Value assignment using assigned reference calibrators, with dose values generated using curves from these reference calibrators.
  • Values are calculated based on recovered values for each run on each instrument independently and then averaged across all systems.
  • Quality control is performed by calculating the recovery of patient samples, spiked patient samples, and controls using the assigned CVM values.

8. The sample size for the training set

• Not applicable for a calibration verification material. There is no "training set" in the context of machine learning or AI for this product. The manufacturing and value assignment processes inherently involve generating data to establish the CVM's characteristics, but this isn't structured as a training set for an algorithm.

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

• Not applicable. See #8.

IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material

This section describes the acceptance criteria and study for the IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (CVM).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the stability study supports the stated claims, which implies the acceptance criteria were met, but does not provide specific performance data points for a direct, side-by-side comparison in the summary.

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

• Test Set Sample Size for Stability:
  • Shelf-life stability: "The CVM study protocols are run as part of the calibrator stability testing. The stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 2."
    • Time points: Day 0, 96 months, 108 months, 120 months for all 4 CVM levels.
    • Therefore, at least 2 replicates x 4 levels x 4 time points = 32 measurements.
  • Open Component (in-use) stability: Stable for 8 hours at ambient or room temperature (15-25°C) after opening. The specific testing methodology and sample size for this claim are not detailed beyond the claim itself.
• Test Set Sample Size for Expected Values/Target Values/Reference Range: "The PAP CVMs were tested on 15 replicates in total comprised of 5 runs and 3 replicates per run on 4 IMMULITE 2000 systems and 3 different reagent kit lots."
• Data Provenance: The document does not explicitly state the country of origin. It is a submission to the FDA (USA). The study is prospective in nature as it is a stability study tracking performance over time.

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

• Not applicable. This device is a calibration verification material for an in vitro diagnostic assay, not an imaging or diagnostic AI requiring expert human interpretation for ground truth. The "ground truth" (assigned dose values) for the CVMs is established through a scientific process involving internal standards and measurement procedures.

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

• Not applicable. This is not a study requiring human adjudication. The results are quantitative measurements against predefined criteria.

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

• Not applicable. This is not an AI/imaging device.

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

• This is an in vitro diagnostic calibration verification material. Its performance is evaluated intrinsically through laboratory testing, essentially a "standalone" evaluation of the material's stability and value assignment, but not in the context of an AI algorithm.

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

• The ground truth for the CVM is its "assigned dose" values. These values are established through:
  • Traceability to an internal standard.
  • Manufacture using qualified materials and measurement procedures.
  • Value assignment using assigned reference calibrators, with dose values generated using curves from these reference calibrators.
  • Values are calculated based on recovered values for each run on each instrument independently and then averaged across all systems.
  • Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values, and controls must fall within their target ranges.
  • Six levels of commercially available controls and 27 samples (22 spiked serum samples and 5 normal female serum samples) were used to validate calibrator/CVM value assignments.

8. The sample size for the training set

• Not applicable for a calibration verification material. There is no "training set" in the context of machine learning or AI for this product.

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

• Not applicable. See #8.

Ask a specific question about this device

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)

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. This assay is intended for in vitro diagnostic use only.

Calcitonin ELISA Test Kit

This document is a 510(k) clearance letter from the FDA for a Calcitonin ELISA Test Kit. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study from the provided input.

Ask a specific question about this device

The intended use of this product is the quantitative determination of Calcitonin in human 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).

Quantitative determination of Calcitonin in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

Here's an analysis of the provided information to describe the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission for the Sangui BioTech, Inc. Calcitonin ELISA primarily relies on demonstrating substantial equivalence to a predicate device. The key acceptance criterion is a strong correlation between the new device and the predicate.

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

• Sample Size: Seventy-seven (77) patient sera.
• Data Provenance: The document does not explicitly state the country of origin. It is a retrospective comparison study as existing patient sera were analyzed using both devices.

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

This type of study does not involve "experts" in the traditional sense for ground truth establishment. The ground truth here is the measurement obtained from the predicate device (Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay), which is considered the established standard. Therefore, no external experts were used to establish ground truth for this comparison.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison of analytical results between two devices, not a scenario requiring adjudication of imaging interpretations or clinical outcomes. The predicate device's results served as the reference.

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 (ELISA kit) for quantitative determination of Calcitonin. It does not involve human readers interpreting images or clinical cases, nor does it involve AI assistance.

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

Yes, this is an inherent standalone performance study. The Calcitonin ELISA kit is a laboratory-based assay, and its performance is evaluated based on its own analytical results compared to a reference method, without human "in-the-loop" decision-making during the analytical process itself. The "algorithm" here is the biochemical reaction and measurement process of the ELISA kit.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used was the results obtained from a legally marketed predicate device, the Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay. This is often referred to as a "comparative ground truth" or "reference method" in analytical performance studies for in vitro diagnostic devices. Additionally, the document mentions another predicate, the Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay, uses the same antibodies and epitopes, further bolstering the claim of equivalence.

8. The Sample Size for the Training Set

Not explicitly stated, nor is a "training set" relevant in the context of this 510(k) submission. This is a comparison of a finished device's performance against a predicate, not a machine learning model requiring training. Any internal development or optimization of the Sangui BioTech ELISA kit would have occurred prior to this submission and would not be typically detailed as a "training set" in this manner.

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

Not applicable, as there is no "training set" in the context of this 510(k) submission for an ELISA kit comparison. The development of the ELISA kit itself would involve established chemical and biological principles and optimization processes, rather than ground truth labeling for a training set.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device