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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.

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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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