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The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Quantitative determination of EPO [Erythropoietin] 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 text regarding the Sangui BioTech, Inc. EPO [Erythropoietin] ELISA kit:

The provided text is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, standalone clinical study for a novel device. Therefore, much of the information typically found in a detailed acceptance criteria and study report for a new device (like a machine learning model) is not explicitly present.

However, we can extract the relevant information and infer some aspects based on the context of a 510(k) submission for an in vitro diagnostic (IVD) device.

Acceptance Criteria and Study Details for Sangui BioTech, Inc. EPO ELISA Kit

Given the context of a 510(k) submission for an ELISA kit, the primary "acceptance criterion" is typically substantial equivalence to a legally marketed predicate device. This is often demonstrated through a correlation study comparing the performance of the new device to the predicate device using patient samples.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The 510(k) summary explicitly lists "The data clearly demonstrates excellent correlation between the two devices" as the primary conclusion, fulfilling the requirement for substantial equivalence.

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

• Sample Size: One hundred twenty-six (126) patient sera samples.
• Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, for a 510(k) for an IVD kit, these are typically clinical samples collected from a relevant patient population, likely from a local US population if the submission is for US market clearance. The samples studied ranged from 5 to 291 mU/mL of EPO as measured by the predicate.

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

• This concept is not directly applicable in the context of this 510(k) submission for an ELISA kit comparison. The "ground truth" for the comparison study is the measurement obtained from the predicate device (Nichols Institute Diagnostics EPO Assay), which is an already legally marketed and accepted device. There are no human experts "establishing ground truth" by interpreting images or clinical data in this type of study.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative assay comparison study, not an imaging-based diagnostic study requiring expert adjudication of reader interpretations.

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 (IVD) device (ELISA kit) and does not involve AI or human readers interpreting outputs in the way an imaging AI diagnostic might.

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

• This is an inherently standalone device as it is an laboratory assay kit. The performance described (correlation with the predicate) represents the performance of the device itself (the "algorithm" or assay chemistry) without human-in-the-loop performance in the sense of a clinical decision-making aid requiring interpretation.

7. The Type of Ground Truth Used

• The "ground truth" for this comparative study is the results obtained from the legally marketed predicate device (Nichols Institute Diagnostics EPO Assay). The study aimed to show that the new Sangui BioTech kit produced results that were statistically equivalent to those of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. ELISA kits, especially in this context, are not "trained" in the machine learning sense. The assay's parameters (e.g., antibody concentrations, incubation times) are developed through laboratory optimization processes, not by feeding data into a training algorithm.

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

• Not applicable, as there is no "training set" or "ground truth for training" in the machine learning sense for this type of device. The assay development involves standard biochemical and immunological optimization.

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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.

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The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

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

The provided text describes the Sangui BioTech, Inc. ACTH ELISA kit and its substantial equivalence to a predicate device. The information primarily focuses on the device's technical characteristics and the study conducted to demonstrate its performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion, though not explicitly stated as a numerical threshold in the document, is implied by the goal of demonstrating substantial equivalency to the predicate device. The primary performance metric used to establish this is the correlation coefficient (R) between the proposed device and the predicate device.

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

• Sample Size for Test Set: One hundred seventeen (117) patient plasma samples.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Not specified in the provided text. It is simply stated that "patient plasma analyzed using both the proposed device and the predicate device."

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

This information is not provided in the text. The study compares the proposed device's performance against a "predicate device" (Nichols Institute Diagnostics ACTH Radioisotopic Assay), not against a 'ground truth' established by human experts in the traditional sense of a diagnostic interpretation study. The predicate device's results are effectively the reference standard in this comparison.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this type of study. The study compares quantitative results from two devices, not subjective interpretations requiring adjudication.

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 applicable/not provided. The study is a comparison of two in vitro diagnostic (IVD) kits, not an AI-assisted diagnostic imaging or interpretation study involving human readers.

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

This study is inherently a standalone performance assessment of the device (an ELISA kit) as it's an in vitro diagnostic test. The device itself performs the quantitative determination; there is no human-in-the-loop component for the device's operation in the context of this evaluation. The comparison is between two automated assay systems.

7. The Type of Ground Truth Used

In this context, the "ground truth" or reference standard for comparison is the results obtained from the predicate device: Nichols Institute Diagnostics ACTH Radioisotopic Assay. The data used for comparison ranged from 1.5 to 1,045 pg/mL of ACTH as measured by the predicate device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable to the evaluation of an ELISA kit in the same way it would be for a machine learning algorithm. An ELISA kit is a biochemical assay, not an algorithm that requires a "training set" to learn from data.

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

This information is not applicable as there is no "training set" for an ELISA kit in the context of its development and validation.

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The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism.

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

The provided document describes a 510(k) premarket notification for the "Sangui BioTech, Inc. INTACT-PTH [Parathyroid Hormone] ELISA" kit. This submission is for demonstrating substantial equivalence to a predicate device, not a de novo clearance requiring extensive clinical studies with specific acceptance criteria in the typical sense of a new medical device. The "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence.

Here's an analysis based on the document:

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

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

• Sample Size for Test Set: One hundred and twenty-three (123) patient sera.
• Data Provenance: Not specified, but generally for 510(k) submissions, given the commercial nature of the companies involved (Sanqui BioTech, Nichols Institute Diagnostics, Diagnostic Systems Laboratories, Inc.), it is highly likely that the data was collected in a prospective manner for the purpose of this submission, or involved retrospective analysis of banked clinical samples. The country of origin is not explicitly stated.

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

This type of information is generally not applicable for a 510(k) submission where the goal is to demonstrate substantial equivalence to an existing device. "Ground truth" in this context is established by the predicate device's measurement, which is assumed to be the accepted standard. No independent experts are typically used to establish a separate "ground truth" for a comparative study like this. The predicate device itself serves as the reference.

4. Adjudication method for the test set

Not applicable. This was a direct comparison study between a new device and a predicate device, not a study requiring adjudication of expert interpretations. The "ground truth" was the measurement provided by the legally marketed predicate device.

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 device is an in vitro diagnostic (IVD) kit for measuring a hormone, not an imaging device or an AI diagnostic tool that assists human readers. Therefore, an MRMC study and discussions of human reader improvement with AI are not relevant to this submission.

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

This concept is also not applicable. The device is a laboratory assay kit. Its "performance" is its ability to accurately measure PTH in a sample. The study demonstrated its performance by comparing its measurements to those of a predicate device. There is no "algorithm only" or "human-in-the-loop" concept in the traditional sense for this type of IVD kit; a human performs the assay according to instructions.

7. The type of ground truth used

The ground truth for the performance evaluation was the measurements obtained from the legally marketed predicate device (Nichols Institute Diagnostics Allégro® Intact PTH kit). The assumption in a 510(k) is that the predicate device provides accurate and clinically acceptable measurements.

8. The sample size for the training set

Not applicable. This is an immunoassay kit (ELISA), not a machine learning or AI model that requires a "training set." The development of the assay (e.g., antibody selection, optimize reagents) would involve internal R&D studies, but these are not referred to as "training sets" in this context.

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

Not applicable, as there is no "training set" in the context of this device's development or the 510(k) submission for substantial equivalence.

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