(1050 days)
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Ventana Medical Systems, Inc. developed the Ventana Anti-CD4 (clone SFCI12T4D11) for use on the Ventana ES automated immunohistochemistry system.
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Acceptance Criteria and Study for K941604
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly derived from the "Results" section, focusing on appropriate and specific staining of CD4 in lymphoid cells and the absence of inappropriate staining.
| Acceptance Criteria | Reported Device Performance (Ventana Anti-CD4) |
|---|---|
| Specific staining of lymphoid cells of CD4 origin (e.g., T cells) | Staining occurred in the plasma membrane of lymphoid cells from normal tonsil, thymus, and blood. |
| Absence of staining in negative control tissue | Negative control tissue was all negative. |
| Absence of inappropriate staining in non-lymphoid tissues | There was no inappropriate staining of the tissues in this study. |
| Sensitivity (appropriate staining of CD4+ cells; no staining of non-CD4+ cells) | Appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. Data agrees with Reinherz et al. |
| Reactivity in T cell lymphomas | Consistent staining of 9 of 9 T cell lymphomas. |
| Reactivity in normal lymphoid tissues | Appropriate staining of normal lymphoid tissues (4/4 peripheral blood lymphocyte cytospins, 4/4 thymus tissues, 10/10 tonsil tissues). |
| Negative control with each tissue producing negative results | The negative control which was run with each tissue gave negative results. |
| Inter-run reproducibility (positive control consistently stains positive across multiple runs) | Same positive control (tonsil) used on 10 different instrument runs; all 10 slides stained positively for CD4 antigen. |
| Intra-run reproducibility (positive control consistently stains positive within a single run) | 10 samples of the same frozen tonsil tissue within one run; all 10 slides stained positively for CD4 antigen. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- T cell lymphomas: 9 samples
- Normal peripheral blood lymphocyte cytospins: 4 samples
- Normal thymus tissues: 4 samples
- Normal tonsil tissues: 10 samples
- Negative control tissue: The text states "Negative control tissue was all negative" but doesn't specify the number of negative control samples.
- Inter-run reproducibility: 1 positive control (tonsil) run 10 times.
- Intra-run reproducibility: 10 samples of the same positive control (tonsil).
- Data Provenance: Samples were obtained from "excess tissues obtained for reasons other than the present study." This indicates the data is retrospective. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 1
- Qualifications: "a qualified pathologist"
4. Adjudication Method for the Test Set
- Adjudication Method: None explicitly stated, as only one pathologist was involved in the evaluation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the antibody itself as evaluated by a single pathologist.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is an immunohistochemistry reagent (antibody) used in a pathological staining process, not an AI algorithm. Its "performance" is its ability to stain specific cellular components, which is then interpreted by a human pathologist. The Ventana ES system is an automated stainer, but the "device" under review here is the anti-CD4 antibody.
7. The Type of Ground Truth Used
- Ground Truth: The ground truth appears to be based on the expert evaluation by a qualified pathologist of the tissue samples, combined with existing knowledge of CD4 distribution in normal and pathological tissues referenced by "Reinherz et al.1". Essentially, it's expert consensus/pathological assessment.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "supporting data" described is for validation of the antibody's performance.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an antibody reagent. The development of the Ventana Anti-CD4 (clone SFCI12T4D11) would have involved extensive R&D and validation steps, but the concept of a "training set" for establishing ground truth isn't relevant in this context.
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510(k) Summary of Safety and Effectiveness
FEB 1 4 1997
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Ventana Medical Systems, Inc. developed the Ventana Anti-CD4 (clone SFCI12T4D11) for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-CD4 (Clone SFCI12T4D11) is substantially equivalent to antibodies detecting cellular elements of Ivmphocvtic origin as reported by Reinherz, et al.1
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Frozen preparations from normal and pathologic samples were tested using the Ventana Anti-CD4 (Clone SFCI12T4D11). Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic and normal tissues were examined. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist for specific staining intensity and background staining.
Results
Staining occurred in the plasma membrane of lymphoid cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.
Sensitivity of the antibody was shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. In addition, the Ventana data in this study agrees with the data published by Reinherz et al.1
The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas. and appropriate staining of normal lymphoid tissues (4 of 4 peripheral blood lymphocyte cytospins. 4 of 4 thymus tissues and 10 of 10 tonsil tissues). As with anv immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control which was run with each tissue gave negative results.
Inter-run reproducibility the same positive control (tonsil) was used on each of 10 different instrument runs. All ten slides stained positively for CD4 antigen.
Intra-run reproducibility was determined based on ten samples of the same frozen tonsil tissue within one run. All ten slides stained positively for CD4 antigen.
'Reinherz EL, Kung PC, Goldstein G, Schlossman SF. A separation of functional subsets of human T cells by a monoclonal antibody. Proc. Natl. Acad. Sci. USA. 1979; 76:4061.
Revised on December 6, 1996
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).