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For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVision FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link), is intended for use in immunohistochemistry together with EnVision FLEX+, High pH visualization kit together with Autostainer Link 48 instrument to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded human breast carcinoma. This antibody labels progesterone receptor-positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Not Found

The provided document is a 510(k) premarket notification for a modification to two existing immunohistochemistry reagents: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use (Link) and FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link).

The modification is specifically for the addition of the new Dako PT Link PT200 as recommended equipment for automated epitope retrieval pre-treatment. This is a special 510(k) submission, meaning it's for modifications to the submitter's own cleared devices where the intended use has not changed, and the fundamental scientific technology remains the same.

Therefore, the document does not contain a performance study designed to establish new acceptance criteria or demonstrate the performance of the device against new criteria. Instead, it relies on the predicate devices' prior clearances and focuses on demonstrating that the modification does not negatively impact the device's functionality or intended use.

Here's an breakdown of why the requested information isn't directly available in this document:

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

   • This document is a modification submission, not an initial clearance. It doesn't present new performance data against specific acceptance criteria for the modified device itself. It hinges on the fact that the intended use has not changed and the fundamental scientific technology has not changed.
   • The "acceptance criteria" here relate to the design control activities for the modification, ensuring that the change (adding a new pre-treatment instrument) does not alter the device's fundamental performance. The document only mentions that the submitter identified "verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied" based on a risk analysis, but it does not provide the actual table of those criteria or the results.

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

   • No new test set data is presented for performance evaluation because the modification does not warrant it in a Special 510(k) (where the fundamental scientific technology and intended use are unchanged).
   • The original clearance (K120663 and K130861) for the predicate devices would contain this information.

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

   • Not applicable to this modification document for the reasons stated above.

4. Adjudication method:

   • Not applicable to this modification document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • Not applicable to this modification document. These are reagents, not AI-powered diagnostic devices.

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

   • Not applicable. These are reagents for immunohistochemistry, which require human interpretation by a pathologist.

7. The type of ground truth used:

   • Not applicable to this modification document. For the original clearances, the ground truth for IHC reagents typically involves expert consensus (pathology review), often comparing staining results to established clinical outcomes or other validated methods.

8. The sample size for the training set:

   • Not applicable. These are reagents, not AI algorithms requiring training sets.

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

   • Not applicable. These are reagents, not AI algorithms.

In summary, this 510(k) is a "Special 510(k)" for a device modification (adding a new recommended pre-treatment instrument to already cleared IHC reagents). It explicitly states that the "INDICATION/INTENDED USE...HAS NOT CHANGED" and the "FUNDAMENTAL SCIENTIFIC TECHNOLOGY...has not changed." Therefore, it does not present new performance data or acceptance criteria for the device itself but rather demonstrates that the modification does not alter the device's previously established performance or intended use.

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For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (LINK) is intended for use in immunohistochemistry with EnVision™ FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma. This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is utilized to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma. This product is pre-diluted and optimized for use with the Dako Autostainer Link 48 automated slide staining platform. Anti-PR, Clone PgR 636 is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The target concentration of Anti-PR, Clone PgR 636 is 0.5 ug/mL; the acceptable concentration range is 0.4 ug/mL to 0.6 ug/mL.

The Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is intended for semi-quantitative detection of human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma using immunohistochemistry with the EnVision™ FLEX+, High pH visualization kit and the Dako Autostainer Link 48 automated slide staining platform. The device's clinical interpretation should be made by a qualified pathologist considering morphological studies, proper controls, patient's clinical history, and other diagnostic tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are not explicitly stated in terms of numerical thresholds for agreement values. However, the study aims to demonstrate "substantial equivalency" to the predicate device, the PR component of the Dako ER/PR pharmDx™ Kit. The reported performance metrics are:

Inter-Laboratory Reproducibility of Anti-PR, Clone PgR 636

The repeated statement of "Study results demonstrate a substantial degree of equivalency to the predicate device" serves as the overarching acceptance criterion, which the provided agreement percentages are used to support.

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

For the concordance study (comparison with the predicate device), the test set involved 236 breast carcinoma samples.
For the reproducibility study, 21 unique breast cancer specimens were used across three testing laboratories over five non-consecutive days, resulting in a total of 315 evaluations.

The document does not explicitly state the country of origin of the data. The studies appear to be retrospective, using formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma samples.

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

The document does not specify the number of experts or their qualifications who established the ground truth for the test set. It mentions that staining was "scored according to ASCO/CAP guidelines (≥1% cut-off)" and that "The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This implies that qualified pathologists were involved in the scoring, but the specific number and their experience levels are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the test set. It refers to scoring "according to ASCO/CAP guidelines" and "Allred scoring guideline described in the package insert" for the predicate, which implies a standardized scoring protocol rather than a specific multi-reader adjudication method (e.g., 2+1, 3+1).

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

A MRMC comparative effectiveness study, in the sense of evaluating how human readers' performance improves with AI vs. without AI assistance, was not done. This device is an immunohistochemistry (IHC) assay, not an AI-assisted diagnostic tool.

However, the reproducibility study can be considered a multi-reader study as it involved testing in "three testing laboratories" over several days for inter-laboratory reproducibility, implying different readers/technicians performing and/or interpreting the tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is an IHC assay, not an algorithm, so a standalone performance study in the context of an algorithm's performance without human intervention is not applicable. The device (the antibody and associated staining platform) is inherently a tool for human interpretation by a pathologist.

7. Type of Ground Truth Used

The ground truth for the concordance study involved comparing the results of the new device (Anti-PR, Clone PgR 636) with those of the predicate device (PR component of the Dako ER/PR pharmDx™ Kit). The results from both were scored based on established guidelines (ASCO/CAP for the new device, and both ASCO/CAP and Allred for the predicate). This suggests a comparative "ground truth" established by an existing, FDA-cleared diagnostic method.

For the reproducibility study, the "ground truth" was based on repeated evaluations of "21 unique breast cancer specimens" scored according to ASCO/CAP guidelines. This would typically involve expert pathologist interpretation to establish the status of the samples.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as this is not an AI/machine learning device. The antibody and assay development would involve internal validation and optimization, but these are not typically referred to as a "training set" in the context of regulatory submissions for IVD reagents.

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

Since there is no explicit "training set" or "ground truth for the training set" in the context of this type of diagnostic reagent, this information is not applicable. The development of such an antibody assay primarily involves analytical validation (specificity, sensitivity, precision) and clinical validation (concordance, reproducibility) against established methods and clinical endpoints.

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For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.

The provided text is a 510(k) Pre-Market Notification for a medical device, specifically the Dako Anti-Human ER $\alpha$ Clone EP1. It describes the device, its intended use, and claims substantial equivalence to a predicate device, but does not contain typical acceptance criteria or a detailed study section with performance metrics like sensitivity, specificity, or concordance rates against a ground truth.

Instead, it states: "Performance characteristics evaluated in support of the Dako Anti-Human ER $\alpha$, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above." However, the actual results of these tests are not present in this document.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, or expert details because this information is not included in the provided text.

The document only states that such studies were performed and showed "substantial equivalency" to the predicate device (ER $\alpha$ component of the Dako ER/PR pharmDx™ Kit, K042884).

If this were a typical AI/ML device submission, a dedicated section detailing these performance characteristics would be expected. Since this is an Immunohistochemistry (IHC) reagent, the performance evaluation methods might differ from those for an image-based AI device.

Without the actual performance data from the specific studies mentioned, I cannot complete the requested information.

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For in vitro diagnostic use.

Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1 is a semiquantitative immunohistochemical (IHC) kit assay to identify estrogen receptor (ER) expression in normal and neoplastic tissues routinely processed and paraffin-embedded.

The provided text describes the Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1, an immunohistochemical (IHC) assay. The document is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results for a novel device.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not explicitly present in the provided text.

Here's an analysis of what can be extracted based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Performance characteristics evaluated for the Estrogen Receptor Clone SP1 IHC assay include results on analytical specificity and sensitivity, precision, reproducibility and method comparison testing." It then states: "Results of all testing conducted substantial equivalence to the predicate device listed above."

This implies that the acceptance criterion was achieving substantial equivalence to the predicate device, especially across these performance characteristics. However, specific numerical targets for these characteristics are not provided.

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

• Sample size: The document does not specify the sample size (number of cases or samples) used for the testing that established substantial equivalence.
• Data provenance: Not explicitly stated. The document refers to "testing conducted," but provides no details on the origin, retrospective, or prospective nature of the data.

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

• Number of experts: Not specified.
• Qualifications: "Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This indicates that pathologists are involved in interpretation but does not detail their role in establishing a ground truth for testing.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• An MRMC study is not mentioned. The focus is on the device's performance against a predicate device, not direct human reader improvement with or without the device.

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

• This device is an IHC antibody, which is a reagent used in a laboratory setting for manual or automated staining, subsequently interpreted by a pathologist. It is not an "algorithm" in the sense of AI. Therefore, the concept of "standalone performance" for an algorithm without a human-in-the-loop is not applicable in this context. The assay itself requires human interpretation.

7. The type of ground truth used:

• The document implies that the ground truth for comparing the new device against the predicate device would be based on the established accuracy of the predicate device and potentially agreement with clinical and morphological findings. The statement "Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls" suggests that the ultimate ground truth incorporates pathological and clinical evaluation, but the specific method for establishing a gold standard for the comparison study is not detailed.

8. The sample size for the training set:

• This device is a biological reagent (antibody), not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set size is not applicable.

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

• As explained above, the concept of a training set is not applicable to this type of device.

In summary:

The provided document is a regulatory submission focused on demonstrating substantial equivalence of a new IHC reagent to an existing one. It does not provide the detailed study design, acceptance criteria, specific performance metrics, or ground truth establishment methods that would be expected for a novel diagnostic algorithm or AI device as the questions imply. The study described is primarily a comparative study to establish equivalency to a predicate, rather than a de novo performance validation with detailed acceptance criteria.

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