Search Results

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.

Ask a specific question about this device