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The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.

The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.

The CCPoint® test is a colloidal gold based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone.

The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad.

In the assay procedure, a sample of serum or plasma is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After a short incubation running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane.

If the sample contains anti-CCP antibodies they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain any anti-CCP antibodies no line will appear. With any sample a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active.

Here's a breakdown of the acceptance criteria and the study details for the CCPoint® kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Immunoscan RA anti-CCP test kit) and providing clinical performance metrics. Explicit "acceptance criteria" for the CCPoint® beyond achieving substantial equivalence and acceptable clinical performance are not explicitly stated as numerical targets in the same way one might see for a completely novel device claim. However, the reported performance serves as the basis for the FDA's substantial equivalence determination.

Implied Acceptance Criteria / Performance Benchmarks (derived from the predicate comparison and clinical performance):

2. Sample Size and Data Provenance (Test Set)

• Sample Size for Predicate Comparison (Table 1a): 1062 frozen retrospective sera.
  • 606 from RA patients
  • 456 apparently healthy blood donors
• Sample Size for Predicate Comparison (Table 1b, subset): 399 samples (extracted from Table 1a, specifically those in the range of 15-1600 U/mL with the ELISA).
• Sample Size for Clinical Sensitivity/Specificity (Table 2 & Specificity Tables): 1815 frozen retrospective sera with clinical characterization.
  • 596 patients with clinically defined RA
  • 456 Blood donors
  • 187 non-RA arthritis
  • 43 Psoriatic arthritis
  • ... (various other disease/control groups listed in the document, totaling 1815)
• Data Provenance: "frozen retrospective sera". The country of origin is not explicitly stated in the provided text.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. It mentions "Patients with clinically defined RA" and "frozen retrospective sera with clinical characterisation," suggesting that clinical diagnoses and medical records were used to categorize samples. However, there's no detail on who made or confirmed these diagnoses, nor any adjudication process by experts specifically for the study.

4. Adjudication Method (Test Set)

No adjudication method (e.g., 2+1, 3+1) is mentioned or described for establishing the ground truth of the test set. The clinical characterization appears to be based on pre-existing diagnoses in the retrospective sera.

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

No MRMC comparative effectiveness study was done. The device is a visually read rapid diagnostic test, and the performance study described is an agreement study against a predicate device and a clinical sensitivity/specificity study against clinical diagnoses. It does not evaluate human readers' improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The CCPoint® is a visually read, qualitative rapid lateral flow test. The performance data presented (percent agreements, sensitivity, specificity) reflects the output of the device itself (the presence or absence of a red line) when interpreted visually according to its intended use instructions by trained laboratory professionals. There is no separate "algorithm" being assessed independent of the visual interpretation of the test result; the visual interpretation is the algorithm's output.

7. Type of Ground Truth Used

• For Predicate Comparison (Tables 1a, 1b): The ground truth was established by the results of the predicate device, Immunoscan RA anti-CCP ELISA.
• For Clinical Sensitivity and Specificity (Table 2 and subsequent specificity tables): The ground truth was "clinical characterization" or "clinically defined RA" for the RA patient group, and diagnostic categories (e.g., "Blood donors," "non-RA arthritis," "Systemic collagen disease") for the control and disease groups. This indicates clinical diagnoses/outcomes information as the ground truth.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or "validation set" in the context of machine learning. This is a diagnostic device comparison and clinical performance study, not an AI/machine learning model development. Therefore, there's no reported sample size for a training set in that sense. The samples used for the performance evaluation are considered a test set.

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

As there is no mention of a traditional "training set" for an AI/ML model, this question is not applicable. The device's mechanism is a biochemical immunoassay, not a learning algorithm that requires a training phase.

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The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. "For in vitro diagnostic use".

The Immunoscan CCPlus® test kit is a modification of the Immunoscan RA anti-CCP Test kit, K052133. It is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. "For in vitro diagnostic use".

The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.

The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.

After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.

Here's a breakdown of the acceptance criteria and study information for the Immunoscan CCPlus® device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The Immunoscan CCPlus® device is a modification of the Immunoscan RA anti-CCP Test kit and its performance is compared to this predicate device. The acceptance criteria are implicitly set by demonstrating substantial equivalence to the predicate device, implying that the modified device's performance characteristics should be similar to or better than the predicate's.

Study Information

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

   • Comparative Agreement Study (Immunoscan CCPlus® vs. Predicate):
     • Sample Size: 628 frozen retrospective sera.
     • Data Provenance: 368 samples from RA patients, 260 samples from apparently healthy blood donors. The country of origin is not specified but is likely Sweden, given the manufacturer's location. The data is retrospective.
   • Clinical Sensitivity and Specificity Study (Immunoscan CCPlus®):
     • Sample Size: 1180 frozen retrospective sera.
     • Data Provenance: The origin of these samples is not specified beyond being "frozen retrospective sera with clinical characterisation." The distribution includes 399 patients with clinically defined RA and various control and disease groups. Country of origin not specified; data is retrospective.

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

   • The document describes the use of "clinically defined RA" for the ground truth of RA patients and "apparently healthy blood donors" or "non-RA diseased patients" for controls.
   • It does not specify the number of experts, their qualifications, or the process by which "clinical characterisation" or "clinically defined RA" was established. This suggests that the ground truth was based on pre-existing clinical diagnoses rather than a panel of experts reviewing the cases specifically for this study.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for establishing the ground truth of the clinical samples. The "clinically defined RA" and control groups appear to have pre-determined diagnoses.

4. 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. This device is an in vitro diagnostic (ELISA) assay that directly measures antibodies. It does not involve human readers interpreting images or data alongside an AI, so an MRMC study is not applicable. The device provides a quantitative or semi-quantitative result directly.

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

   • Yes, this is a standalone device in the sense that the test results are generated by the assay without real-time human interpretation affecting the output. The assay produces a direct quantitative or semi-quantitative result for anti-CCP antibodies. The results are then used by trained laboratory professionals in conjunction with other clinical findings.

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

   • The ground truth for the clinical sensitivity and specificity study was based on clinical characterization/diagnosis, specifically "clinically defined RA" for the RA group and various diagnosed control groups (e.g., SLE, IBD, blood donors, etc.) for the non-RA groups. This implies a combination of clinical symptoms, other laboratory findings, and possibly imaging, leading to a physician's diagnosis. It is not explicitly stated to be expert consensus, nor pathology or direct outcomes data, but rather an established clinic diagnosis.

7. The sample size for the training set:

   • The document does not specify a training set. This is typical for traditional in-vitro diagnostic assays, which are usually developed using analytical methods and then validated with clinical samples, rather than "trained" in the machine learning sense. The information provided pertains solely to the validation/test sets.

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

   • Since no training set is mentioned for an algorithm, this question is not applicable. For an ELISA kit, development involves optimizing reagents and protocols against known positive and negative samples, but this isn't typically referred to as "training" in the same way as AI/ML.

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The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.

The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. Trained laboratory professionals should perform the analysis. "For in vitro diagnostic use".

The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.

The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.

After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.

Here's a breakdown of the acceptance criteria and study details for the EDIA™ anti-CCP kit, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device and establish clinical performance characteristics. The reported device performance is as follows:

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The Euro-Diagnostica Immunoscan Anti-GBM Kit is an enzyme immunoassay (EIA) kit for the in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum. This kit is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

enzyme immunoassay (EIA) kit

This document is a 510(k) clearance letter for the Immunoscan Anti-GBM Kit, an in vitro diagnostic device. It does not contain the detailed information required to answer the specific questions about acceptance criteria, study design, and performance metrics typically associated with AI/ML device evaluations. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information from the provided text. The document does not describe:

1. Acceptance criteria or reported device performance
2. Sample sizes or data provenance for test sets
3. Number or qualifications of experts for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
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

The document is a regulatory approval notice, not a study report or technical specification for the device's performance.

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The Euro-Diagnostica Immunoscan MPO-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Euro-Diagnostica Immunoscan Anti-Myeloperoxidase Antibodies (MPO-ANCA) Kit, stating its substantial equivalence to a predicate device.

While it mentions the "indications for use," it lacks specific details about:

• Acceptance Criteria: What quantitative or qualitative metrics the device needed to meet.
• Reported Device Performance: Actual sensitivity, specificity, accuracy, or other performance metrics from a study.
• Study Design Details: Sample sizes, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, ground truth types, training set information, or how ground truth was established.

The document primarily confirms that the device is cleared for marketing based on its substantial equivalence to an existing device and specifies its intended use: "an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against myeloperoxidase to be used as an aid in the diagnosis of crescentic glomerulonephritis."

To provide the information you requested, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, clinical study reports, or a performance evaluation section.

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The Euro-Diagnostica Immunoscan PR3-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against proteinase-3 to be used as an aid in the diagnosis of Wegener's granulomatosis.

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This document is a 510(k) clearance letter for the Euro-Diagnostica Immunoscan PR3-ANCA Kit. It does not contain detailed information about the acceptance criteria or the study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information from the provided text.

The provided text is a regulatory clearance letter and does not contain the detailed study design or results used to establish performance or acceptance criteria.

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