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The REAADS Protein C Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of plasma levels of human Protein C (as a percent of normal concentration) by enzyme linked immunosorbent assay (ELISA). Plasma levels of Protein C may be used in conjunction with other assays as an aid in diagnosing congenital or acquired Protein C deficiencies associated with thrombotic disease.

The REAADS Protein C Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). The capture antibody specific for human Protein C is coated to 96 microwell polystyrene plate. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody bound to the plastic. The plates are washed to remove any unbound Protein C or other plasma molecules. Bound Protein C is quantitated using an HRP conjugated anti-human Protein C detection antibody. Any unbound conjugated anti-human Protein C is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. Protein C Antigen relative percent concentrations in patient plasma is determined against a curve made from a reference plasma.

The provided text describes the REAADS Protein C Antigen Test Kit, an in vitro diagnostic assay. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided information:

Acceptance Criteria and Study Details for REAADS Protein C Antigen Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The text mentions "Test results for clinical samples" and "the entire population" for the correlation analysis, but does not provide a specific number of samples.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It refers to "patient plasma" and "clinical samples," suggesting human samples.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable for this type of device. This device is an in vitro diagnostic assay that measures Protein C antigen levels. The "ground truth" for its performance is typically established by comparing its quantitative measurements to a reference method or a validated predicate device, not by expert consensus on interpretations.

4. Adjudication Method

• Not applicable. See explanation above. The performance evaluation relies on quantitative comparison between assays, not subjective interpretation requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No. This is not an imaging or diagnostic interpretation device where human readers are involved in the direct output that is being compared. The study compares the quantitative results of two laboratory tests.

6. Standalone Performance Study

• Yes, a standalone comparison was performed. The study directly compares the quantitative results of the REAADS Protein C Antigen Test Kit (algorithm only, as it's an ELISA test) to a predicate device (Helena Protein C Antigen Rocket EID Method). The results reported (r=0.949, p=0.838) are indicative of the device's standalone performance compared to the predicate.

7. Type of Ground Truth Used

• Comparison to a Legally Marketed Predicate Device. The "ground truth" or reference standard for this substantial equivalence claim is the performance of the Helena Protein C Antigen Rocket EID Method. The study directly compares the REAADS kit's results to those obtained using the Helena method.

8. Sample Size for the Training Set

• Not applicable. This device is a quantitative assay, not a machine learning model that requires a "training set" in the typical sense. Product development for such assays involves internal validation and optimization, but the term "training set" is not relevant here.

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

• Not applicable. As a quantitative assay, there is no "training set" for ground truth in the machine learning context. The assay's analytical performance (e.g., sensitivity, specificity, accuracy, precision) is established through laboratory experiments and comparison to established methods or reference materials.

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The REAADS Protein S Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of Total and Free Protein S levels in human plasma (as a percentration) by enzyme-linked immunosorbent assay (ELISA). Plasma levels of Protein S may be used in conjunction with the results from other assays as an aid in diagnosing congenital or acquired Protein S deficiencies associated with thrombotic disease.

The REAADS Protein S Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). A capture antibody specific for human Protein S is coated to 96-microwell polystyrene plate. Diluted patient plasma is incubated in the wells, allowing any available Protein S to bind to the anti-human Protein S antibody on the microwell surface. The plates are washed to remove any unbound plasma molecules. Bound Protein S is quantitated using an HRP conjugated anti-human Protein S detection antibody. Any unbound conjugated antihuman Protein S is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. Protein S relative percent concentrations in patient plasma are determined against a curve prepared from a reference plasma provided with the kit. Results obtained from diluted plasma samples not pretreated with polyethylene glycol (PEG) represent the Total Protein S concentration from that sample. To measure Free Protein S, PEG is added to plasma samples prior to beginning the assay to precipitate the Protein S-C4b binding protein complex. The supernatant fraction containing Free Protein S may be tested along with the untreated plasma sample. Both Total (untreated) and Free (PEG-treated) Protein S concentrations are determined following the same assay procedure described using separate reference curves.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Sample Size: Not specified in the provided text, only referred to as "clinical samples."
   • Data Provenance: Not specified in the provided text. It is unclear if it's retrospective or prospective or the country of origin.

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

   • Not applicable. The study compares the new device to existing legally marketed predicate devices, not against expert-established ground truth for diagnosis/classification.

4. Adjudication Method for the Test Set:

   • Not applicable. The study is a comparative performance study against predicate devices, not one requiring adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC study was not done. The study compares the performance of the new device against predicate devices using quantitative measurements of Protein S levels.

6. Standalone Performance (Algorithm only without human-in-the-loop performance):

   • Yes, this is a standalone performance study. The REAADS Protein S Antigen Test Kit is an in vitro diagnostic assay that produces quantitative results directly. Human intervention is involved in conducting the assay and interpreting the results in a clinical context, but the performance evaluation here specifically focuses on the accuracy of the assay itself in determining Protein S levels compared to existing methods.

7. Type of Ground Truth Used:

   • The "ground truth" for this study is the results obtained from legally marketed predicate devices: the Helena Protein S Antigen Rocket EID Method and the Helena Free Protein S Reagent. The study aims to demonstrate substantial equivalence to these established methods.

8. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning model, so there is no "training set." The device is a laboratory assay.

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

   • Not applicable, as there is no training set for this type of device.

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The REAADS von Willebrand Factor Antigen (vWF:Ag) Test kit is an in vitro diagnostic assay for the quantitative determination of human plasma levels of vWF:Ag (as a percent assay to throncentration) by enzyme linked immunosorbent assay (ELISA). Plasma levels of vWF:Ag may be used as an aid in diagnosing von Willebrand disease.

The REAADS von Willebrand Factor Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). The capture antibody specific for human vWF is immobilized to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available vWF:Ag to bind to the anti-human vWF antibody bound to the plastic. The plates are rinsed to remove any unbound plasma vWF:Ag molecules. Bound vWF:Ag is quantitated using an HRP conjugated anti-human vWF detection antibody. Any unbound conjugated anti-human vWF is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. vWF:Ag relative percent concentrations of patient plasma is determined against a curve made from a reference plasma provided.

Here's an analysis of the provided text regarding the REAADS von Willebrand Factor Antigen Test Kit, extracting the requested information:

Acceptance Criteria and Study Details for REAADS von Willebrand Factor Antigen Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the REAADS vWF:Ag Test Kit is compared to a legally marketed predicate device (Helena Von Willebrand Factor Antigen Rocket EIA) and a substantial equivalence claim is made. The acceptance criteria are implied by the statistical results presented to demonstrate this equivalence. Specifically, a high coefficient of correlation and a non-significant P-value (>.05) typically demonstrate statistical similarity and thus medical equivalence.

2. Sample Size for the Test Set and Data Provenance

The document refers to "Test results for clinical samples" but does not specify the exact sample size used for the test set.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It only mentions "clinical samples."

3. Number of Experts and their Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. The comparison is made against a predicate device.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Since a comparison was made against a predicate device's results directly, and not against an expert-adjudicated ground truth, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This device is an in-vitro diagnostic test, not typically evaluated with MRMC studies involving human readers and AI assistance.

6. Standalone Performance Study

A standalone performance study was implicitly done by comparing the REAADS vWF:Ag Test Kit to the predicate device. The comparison directly evaluates the algorithm's (test kit's) performance against another established method.

7. Type of Ground Truth Used

The ground truth for the test set was essentially the results obtained from the legally marketed predicate device, the Helena Von Willebrand Factor Antigen Rocket EIA.

8. Sample Size for the Training Set

Not applicable/Not mentioned. This is a traditional ELISA-based test kit and does not involve AI or machine learning models that typically have "training sets." The development of such kits involves assay optimization and validation, not model training.

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

Not applicable/Not mentioned. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it does not apply. The development would involve analytical validation and calibration using known concentrations of vWF:Ag.

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