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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 Scantibodies Laboratory, inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Whole PTH (1-84) ImmunoChemiluminoMetric (ICMA) Assay

This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested criteria (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or typically not included in such submissions for IVD assays.

However, I can extract the relevant information regarding the device and its intended use. Here's a breakdown based on the provided text:

Device: Whole PTH (1-84) ImmunoChemiluminoMetric (ICMA) Assay

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device. Specific performance characteristics and acceptance criteria are usually detailed in the 510(k) summary document itself, which is not fully included here. The clearance letter only verifies that the FDA has reviewed the submission and determined substantial equivalence.

Therefore, a table of specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and reported device performance (e.g., observed precision, accuracy) cannot be extracted directly from this clearance letter. These details would be found within the full 510(k) submission.

What can be inferred from the clearance: The device met the acceptance criteria required for substantial equivalence to a legally marketed predicate device. This implies that its performance (e.g., analytical sensitivity, specificity, precision, accuracy, linearity) was demonstrated to be comparable enough to the predicate to be considered safe and effective for its intended use.

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

• Sample Size for Test Set: Not explicitly stated in this clearance letter.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated in this clearance letter.

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

• Number of Experts: Not applicable for an IVD assay where performance is primarily analytical (chemical/biological), not based on expert interpretation of images or clinical findings.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable for an IVD assay. Ground truth would be established through reference methods or clinical diagnosis, not expert adjudication of subjective results.

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:

• MRMC Study: Not applicable. This is an IVD assay, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

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

• Standalone Performance: For an IVD, standalone performance refers to its analytical performance (e.g., accuracy, precision, linearity) when run as specified by the manufacturer. This would have been assessed as part of the 510(k) submission to demonstrate substantial equivalence, but the specific metrics are not detailed in this clearance letter. The device itself is "algorithm only" in the sense that it's an automated chemical assay.

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

• Type of Ground Truth: For an IVD like this, ground truth would typically be established through:
  • Reference analytical methods: Comparing the device's results to a recognized gold standard method for measuring PTH.
  • Clinical diagnosis: Correlating PTH levels with patient diagnoses of hypercalcemia or hypocalcemia established through other clinical findings, lab tests, and expert opinion (though not "expert consensus" on the device's reading, but rather the patient's overall condition).

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable in the context of an IVD assay. IVDs are developed and validated through analytical studies and clinical studies, but generally don't involve "training sets" in the machine learning sense. Assay parameters are optimized and calibrated during development.

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

• Ground Truth for Training Set: Not applicable for an IVD assay. Calibration and optimization during development would use characterized samples, but not a "training set" with ground truth in the AI/ML context.

Summary for this specific device:

• This is an ImmunoChemiluminoMetric Assay (ICMA) for measuring Whole PTH (1-84) in plasma.
• It's classified as an In Vitro Diagnostic (IVD) device.
• The FDA clearance confirms substantial equivalence to a predicate device, meaning its performance for the stated indications is considered comparable to existing legally marketed devices.
• The Indications for Use: "The Scantibodies Laboratory, inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism."
• Details on specific performance metrics, sample sizes, and ground truth establishment methods (which would be analytical validation data) are not part of this 510(k) clearance letter but would have been part of the full submission.

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The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of a crother incone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay

This is an FDA premarket notification (510(k)) letter for an in vitro diagnostic device, the Scantibodies Laboratory, Inc. Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay. This type of document, particularly from 2006, generally does not contain detailed study information, acceptance criteria, or performance data in the same way that a more recent AI/ML device approval would.

510(k) clearances typically establish substantial equivalence to a legally marketed predicate device, and the detailed performance data, acceptance criteria, and study methodologies are usually filed with the FDA and summarized in publicly available summaries if these were required as part of the 510(k) submission. However, the letter itself primarily focuses on the regulatory decision.

Based on the provided text, I can extract the following:

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

The provided document does not contain any acceptance criteria or reported device performance. The letter is a regulatory announcement of clearance, not a summary of the underlying validation studies.

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

The provided document does not specify the sample size for the test set or the data provenance.

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):

The provided document does not mention the number of experts or their qualifications for establishing ground truth. For an in vitro diagnostic assay, the "ground truth" would typically be established through reference methods or clinical diagnosis, not by experts reviewing images.

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

The provided document does not describe any adjudication method.

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 device is an ImmunoChemiluminoMetric (ICMA) Assay, which is a laboratory test for measuring parathyroid hormone. It is not an AI-powered image analysis device or a device that involves human readers. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable to this type of device.

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

This device is a standalone laboratory assay. Its performance is evaluated intrinsically, not in the context of human-in-the-loop performance. Its performance would be evaluated against established analytical performance metrics (e.g., precision, accuracy, limit of detection, linearity), which are not detailed in this clearance letter.

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

For this type of in vitro diagnostic assay measuring a biomarker (parathyroid hormone), the "ground truth" in validation studies would typically be established by:

• Correlation with a reference method or a legally marketed predicate device (as implied by the 510(k) process for substantial equivalence).
• Correlation with clinical diagnosis of hypercalcemia or hypocalcemia (e.g., from patient records, physician diagnosis).
• Pathology is not directly applicable here as it's not a tissue-based diagnostic. Outcomes data might be used to assess clinical utility but isn't typically the primary ground truth for an assay's analytical performance.

However, the provided document does not explicitly state the type of ground truth used for its studies.

8. The sample size for the training set:

The provided document does not specify the sample size for any training set. As this is not an AI/ML device, the concept of a "training set" in the machine learning sense is not applicable. For traditional IVD assays, there might be studies for method development and optimization, but they wouldn't be termed "training sets."

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

Not applicable, as this is not an AI/ML device with a "training set."

In summary: The provided document is a 510(k) clearance letter from the FDA for an immunoassay. It confirms regulatory approval based on substantial equivalence to a predicate device but does not contain the detailed study design, acceptance criteria, or performance results that would be submitted to the FDA as part of the application. Many of the requested details are specific to AI/ML device evaluations and are not relevant or present for a traditional immunoassay from 2006.

Ask a specific question about this device

The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Total Intact PTH Immunoradiometric Assay (Coated Tube Version)

This document is a 510(k) premarket notification from the FDA for a medical device called "Total Intact PTH Immunoradiometric Assay (Coated Tube Version)". It primarily concerns the regulatory approval of the device and does not contain detailed information about acceptance criteria or specific study results as would be found in a clinical study report.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices...". This implies that the device met certain criteria for substantial equivalence, but the specific acceptance criteria and the device's performance against them are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.

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 information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.

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 information is not provided in the document. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool, so an MRMC study with human readers improving with AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a laboratory assay, which by its nature operates "standalone" in terms of generating a measurement. However, performance data for this "standalone" operation is not provided in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an in-vitro diagnostic device like this, the "ground truth" would typically refer to a reference method or a clinical diagnosis (e.g., confirmed hypercalcemia/hypocalcemia) against which the assay's measurements are compared. This specific information is not provided in the document.

8. The sample size for the training set:
This information is not provided in the document.

9. How the ground truth for the training set was established:
This information is not provided in the document.

Ask a specific question about this device

The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma and serum. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Not Found

This document is a 510(k) premarket notification approval letter for the Scantibodies Laboratory, Inc. Whole PTH Immunoradiometric (IRMA) Tube Assay. It declares the device substantially equivalent to legally marketed predicate devices.

The information provided does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. This type of regulatory letter confirms the device's market clearance but does not typically contain the detailed technical study information that would be present in a submission's supporting data section.

Therefore, I cannot provide the requested table and information based on the given text.

Ask a specific question about this device

The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Not Found

This document is a marketing approval letter from the FDA for a medical device called "Whole PTH ImmunoChemiluminoMetric (ICMA)." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

• Acceptance criteria or reported device performance.
• The study that proves the device meets acceptance criteria.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the given input. This document is solely an FDA approval letter and does not include the technical details of the device's validation studies.

Ask a specific question about this device

The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay." This document primarily focuses on the regulatory clearance process and does not contain specific details about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert ground truth establishment, or similar scientific study details typically found in a clinical trial report or scientific publication.

Therefore, I cannot provide the requested information based on the given text. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it doesn't describe the studies that led to that determination in the detail you're asking for.

To answer your questions, I would need access to the actual 510(k) submission document or a detailed performance study report for the device.

Ask a specific question about this device

The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assay

The provided document is a 510(k) clearance letter from the FDA for a device called "ACTH Immunoradiometic (IRMA) Assay" manufactured by Scantibodies Laboratory, Inc. This letter primarily confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain the specific acceptance criteria, study details, or performance data that would typically be found in a study report or a more detailed submission. It states that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. The information provided is primarily administrative and regulatory.

Therefore, based solely on the provided text, I cannot generate the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because that specific data is not present in this regulatory clearance letter.

To provide the requested information, a different document, such as a summary of safety and effectiveness, the 510(k) submission itself, or a published study report, would be needed.

Ask a specific question about this device

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document discusses:

• The device name: Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay
• Regulation Number and Name: 21 CFR 862.1545, Parathyroid hormone test system
• Regulatory Class: Class II
• Intended Use: To measure PTH levels in serum and plasma for differential diagnosis of hypercalcemia and hypocalcemia.
• The 510(k) number: K031534

It does not provide details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assav

This appears to be a 510(k) premarket notification approval letter for a medical device (ACTH Immunoradiometric (IRMA) Assay) and not a study report. Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

Specifically, the document is an FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, or ground truth establishment for a test set.
• Information on expert adjudication or qualifications.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• Details on the sample size or ground truth for a training set.

The document only states the "Indications For Use" of the ACTH IRMA Assay.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device