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The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use.

The AquaLite® hGH Bioluminescent Immunoassay Kit uses a mouse monoclonal anti-hGH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples or appropriate calibrators or controls, are pipetted (150 uL) into the precoated tubes. A sheep anti-hGH antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. hGH in the sample combines with the antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 120-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.

The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the hGH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the hGH calibrators is plotted against hGH concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to hGH concentration in ng/mL.

Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

Here's an analysis of the provided text regarding the AquaLite® Human Growth Hormone Assay, broken down by your requested categories:

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

The document does not explicitly state "acceptance criteria" as a set of pre-defined thresholds. Instead, it presents performance characteristics determined through studies. The implication is that these reported performance characteristics were deemed acceptable by the FDA for substantial equivalence to the predicate device.

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The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.

The DSL Active IGF-1 ELISA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum. This ELISA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the microtitration wells. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the anti-IGF-I antibody conjugated to the enzyme horseradish peroxidase.

Here's an analysis of the provided text regarding the DSL 10-2800 IGF-I ELISA Kit, focusing on acceptance criteria and study details.

Based only on the provided text, the concept of "acceptance criteria" is implicit rather than explicitly stated with numerical targets for performance metrics like sensitivity or specificity. The primary reported performance metric is the correlation coefficient (r) between the new device and a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this Context: The document describes a "Summary of Safety and Effectiveness" for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device. In this regulatory pathway, demonstrating substantial equivalence often involves showing comparable performance, rather than meeting pre-defined, absolute performance thresholds (like 90% sensitivity). The strong correlation (r = 0.82) and the linear regression are presented as the evidence of this comparable performance.

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

• Sample Size: 319 patient samples.
• Data Provenance: The text states "patient samples...were collected." It does not specify the country of origin. Given the submitter's address is in the USA ("Webster, Texas, USA"), it is most probable the data is from the USA, but this is not explicitly stated. The nature of the study (comparing a new device to an existing one) suggests elements of both retrospective (analyzing existing samples) and prospective (collecting samples specifically for this comparison) could be involved, but the text doesn't specify. However, "samples were collected" often implies prospective collection for the purpose of the study.
• Selection: "Samples were chosen based on expected IGF-I levels so that samples with low, intermediate and high levels of IGF-I would be evaluated." This indicates a targeted selection rather than a purely random sample.

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

• Not Applicable / Not Mentioned. For this type of in vitro diagnostic device comparison study (comparing two assays that measure the same analyte), "ground truth" isn't typically established by human expert consensus on images or observations. Instead, the "truth" for comparison is the result obtained from the predicate device (DSL 2800 IGF-I IRIMA).

4. Adjudication Method for the Test Set

• Not Applicable / Not Mentioned. Adjudication methods (like 2+1, 3+1) are typically used when human readers or clinicians disagree on an interpretation, and a third party resolves the discrepancy. This study compares quantitative measurements from two laboratory assays. Discrepancies would be analyzed statistically, not through human adjudication in the traditional sense.

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

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This study is not a medical imaging or AI-assisted diagnostic study involving human readers. It's a comparison of two in vitro diagnostic (IVD) assays.

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

• Yes, a standalone study was done. This study evaluates the DSL 10-2800 IGF-I ELISA Kit as a standalone assay, directly comparing its quantitative results to a predicate device. There is no human interpretation component described in the performance evaluation presented.

7. The Type of Ground Truth Used

• Reference Method Comparison / Predicate Device Results. The "ground truth" for this study is essentially the results obtained from the DSL 2800 IGF-I IRIMA, which is the predicate device. The new device's performance is measured by its agreement with this established method.

8. The Sample Size for the Training Set

• Not specified. The document describes a performance evaluation for substantial equivalence, which is typically a validation study using a test set. It does not mention a "training set" for the development of the DSL 10-2800 IGF-I ELISA Kit. ELISA kits are developed through biochemical and immunoassay optimization, not typically through machine learning training sets in the same way an AI algorithm would be.

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

• Not applicable / Not mentioned. As there's no training set described in the context of an AI/machine learning model, the concept of "ground truth for the training set" as it relates to expert consensus or pathology is not relevant here. The "training" for an ELISA kit involves optimizing reagents, concentrations, and protocols to achieve desired performance characteristics.

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The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

The DSL 1900 hGH IRMA kit was developed for the quantitative measurement of hGH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample.

The provided text describes a DSL 1900 hGH IRMA Kit, an immunoradiometric assay for the quantitative determination of human growth hormone (hGH) in human serum. The primary "study" described is a method comparison study to demonstrate substantial equivalence to a predicate device, the DSL 10-1900 hGH ELISA.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here is implied by the goal of demonstrating substantial equivalence to the predicate device. The performance is measured by the linear regression analysis and correlation coefficient.

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

• Sample Size for Test Set: 68 human serum samples
• Data Provenance: Human serum samples were collected. The text does not specify the country of origin. It is a retrospective analysis of collected samples.

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

This question is not applicable in the context of this device and study. The "ground truth" for a quantitative diagnostic assay of this type is typically the result from a reference method or a highly validated predicate device. In this case, the DSL 10-1900 hGH ELISA serves as the reference for comparison. There is no mention of expert human readers or their qualifications being used to establish ground truth for this type of assay.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison study, not a study involving human interpretation that would require adjudication. The results from each assay (DSL 1900 hGH IRMA and DSL 10-1900 hGH ELISA) are directly compared.

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

No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison, not a study evaluating human reader performance with or without AI assistance.

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

Yes, in a sense, a standalone performance was done. Both assays (the investigational DSL 1900 hGH IRMA and the predicate DSL 10-1900 hGH ELISA) operate as standalone laboratory tests without human-in-the-loop performance during the measurement phase. The study compares the results generated directly by these "algorithms" (i.e., the assay procedures and their interpretation based on standard curves).

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence study is the results obtained from the predicate device, the DSL 10-1900 hGH ELISA. This predicate device is considered a validated method for measuring hGH.

8. The Sample Size for the Training Set

Not applicable. This document describes a method comparison study to demonstrate substantial equivalence, not the development or training of an AI algorithm or a machine learning model. Therefore, there is no "training set" in the context of AI/ML. All 68 samples were used for the comparison study.

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

Not applicable, as there is no training set in the AI/ML sense.

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The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.

The DSL 9100 IGF-II IRMA kit was developed for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube, the other antibody, mouse monoclonal anti-IGF-II is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound IGF-II is directly proportional to the concentration of the IGF-II present in the sample.

This document is a Summary of Safety and Effectiveness for the DSL 9100 IGF-II IRMA Kit. It describes an In Vitro Diagnostic (IVD) device, specifically an immunoradiometric assay (IRMA) for quantitatively measuring Insulin-like Growth Factor-II (IGF-II) in human serum or plasma.

The provided document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic study involving patient data, nor does it describe a study that uses such data to prove the device meets acceptance criteria.

Instead, the document focuses on:

• The name and classification of the device.
• The submitter information.
• The assay principle (IRMA format, sandwich immunoassay with radiolabeled antibody).
• The intended use (in vitro diagnostic for evaluation of growth status).
• A statement of substantial equivalence to the DSL IGF-I IRMA.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The document is a regulatory submission summary, not a detailed clinical performance study report.

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The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders.

The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with lodine-125.

The provided document describes a medical device, the "DSL 2800 IGF-I IRMA Kit," for the quantitative measurement of Insulin-like Growth Factor-I (IGF-I). It details the device's intended use and compares it to a substantially equivalent device, the "DSL 5600 IGF-I IRMA."

However, the provided text does not contain information related to acceptance criteria, detailed study designs, expert involvement, or any aspects of AI/algorithm performance. The document is a summary of safety and effectiveness, focusing on demonstrating substantial equivalence between two kits by comparing their measurement results on patient samples.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions because the necessary information is not present in the input text.

Here's what I can extract and what is missing based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance:
  • Comparison with DSL 5600 IGF-I IRMA: Y = 1.19(X) - 22.07 (Linear regression equation)
  • Correlation Coefficient (r): 0.98

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

• Sample Size for Test Set: 146 patient samples.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified, but samples were "collected and assayed simultaneously by both methods," suggesting a prospective collection or at least simultaneous testing of existing samples. The selection based on "expected IGF-I levels" implies a targeted, rather than purely random, selection.

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):

• Not applicable. This is a measurement assay comparison, not an expert-driven diagnostic interpretation. "Ground truth" in this context is established by the reference assay (DSL 5600 IGF-I IRMA) on the same samples.

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

• Not applicable. There's no adjudication process described as it's a quantitative measurement comparison, not an interpretation task.

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:

• No MRMC study was done. This document describes a comparison between two lab assay kits, not an AI system or human reader performance.

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

• Not applicable. This device is a diagnostic assay kit, not an algorithm or AI system. Its performance is inherent to the kit's chemical and immunological reactions.

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

• For the purpose of demonstrating substantial equivalence, the "ground truth" was defined by the results obtained from the DSL 5600 IGF-I IRMA kit on the same patient samples. This kit is presented as the substantially equivalent device to which the new device (DSL 2800 IGF-I IRMA Kit) is being compared.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set. The assay's performance is based on its chemical and immunological design.

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

• Not applicable. No training set for an AI model is described.

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The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme.

This document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a diagnostic device, specifically the "DSL 10-1900 hGH ELISA Kit". It describes the device, its intended use, and a study comparing it to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the new device's performance. Instead, it compares the new device to a predicate device (Nichols Institute hGH IRMA) to show "substantial equivalence." The reported performance relates to this comparison.

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

• Sample Size: 41 patient samples
• Data Provenance: The document does not specify the country of origin. It states "patient samples were collected," implying they are retrospective or a convenience sample collected specifically for the study. It doesn't indicate if they were collected prospectively.

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

This information is not provided in the document. For an ELISA kit, "ground truth" would typically be established by laboratory reference methods or expert clinical interpretation of patient conditions, but the text focuses on comparing the new ELISA to another established ELISA.

4. Adjudication method for the test set

This information is not provided in the document, as the study is a direct comparison of two assays rather than a human-reader-based assessment 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

No, an MRMC comparative effectiveness study was not done. This document describes an in-vitro diagnostic (IVD) device (ELISA kit) for measuring a biomarker, not an AI or imaging device that would typically involve human readers.

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

The entire study described is a standalone performance of the DSL hGH ELISA kit compared to the Nichols Institute hGH IRMA kit. Both are automated or semi-automated laboratory assays, not requiring human "in-the-loop" interpretation in the same way an AI imaging algorithm might.

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

The document implies that the Nichols Institute hGH IRMA served as the de-facto "ground truth" or reference method against which the new DSL hGH ELISA Kit was compared to establish substantial equivalence. It's a comparison against an existing, presumably validated, diagnostic assay.

8. The sample size for the training set

This information is not provided in the document. For an ELISA kit, training would typically involve assay development and optimization (e.g., reagent concentrations, incubation times), not a "training set" in the machine learning sense. The 41 samples discussed are for the equivalence comparison, not for training.

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

This information is not applicable as there is no mention of a "training set" or "ground truth" for it in the context of this ELISA kit's development and validation in this document. The "ground truth" concept applies more directly to the comparison study described in point 7.

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