(266 days)
No
The device description focuses on the antibody, detection reagents, and automated staining instrument. The interpretation is performed by a qualified pathologist using bright-field microscopy. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended for in vitro diagnostic (IVD) use to aid in the identification of certain lymphomas by detecting the CD30 protein, not for treating any condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the assay "may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL)," and that the "antibody is intended for in vitro diagnostic (IVD) use." This indicates its role in disease diagnosis.
No
The device description explicitly states that the assay consists of the primary antibody, detection reagents, and an instrument (BenchMark ULTRA automated staining instrument), indicating it is a hardware and reagent-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This antibody is intended for in vitro diagnostic (IVD) use."
- Intended Use: The device is intended for the qualitative detection of a protein (CD30) in tissue samples to aid in the identification of specific lymphomas. This is a diagnostic purpose performed outside of the living body (in vitro).
- Laboratory Use: The intended use specifies "for laboratory use," which is typical for IVD devices.
- Interpretation by Qualified Pathologist: The interpretation of the results is done by a qualified pathologist, which is consistent with the use of diagnostic tools in a clinical setting.
N/A
Intended Use / Indications for Use
The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument and OptiView DAB IHC Detection Kit. CD30 positive staining may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.
Product codes
DEH
Device Description
The VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber-H2) antibody, detection reagents and an instrument (BenchMark ULTRA automated staining instrument).
The VENTANA CD30 (Ber-H2) Assay is a mouse monoclonal antibody (IgG1, kappa) directed against CD30. CD30 antigen is expressed in mononuclear Hodgkin's cells and multinucleated Reed Sternberg cells of Hodgkin Lymphoma as well as on anaplastic large cell lymphomas. This antibody variably produces membranous, cytoplasmic, and Golgi staining of both lymphoma cells and of scattered large activated B and T cells in lymph nodes, spleen, tonsil, and thymus.
The OptiView DAB IHC Detection Kit is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit primary antibodies. This kit is intended to detect antigens by IHC in sections of formalin-fixed, paraffin-embedded (FFPE) and frozen tissues that are stained on the BenchMark ULTRA instrument (note: the VENTANA CD30 (Ber-H2) Assay will not be recommended for use in frozen tissue). The OptiView DAB IHC Detection Kit produces a visible dark brown precipitate (3, 3'-Diaminobenzidine) via a horseradish peroxidase (HRP) enzymatic reaction at the antigen site. The Pathologist evaluates the brown precipitate using Bright-field microscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Formalin-fixed, paraffin-embedded tissue.
Human tissue.
Lymph nodes, spleen, tonsil, and thymus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory use.
Qualified pathologist.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical (analytical) performance testing has been conducted to demonstrate performance characteristics of VENTANA CD30 (Ber-H2) Assay. Method Comparison studies have demonstrated substantial equivalence to predicate device (Dako K965022).
The results of testing have been compared between VENTANA CD30 (Ber-H2) Assay and the DAKO K965022 device through a premethod comparison study. The results of the study show a 91.0% (517-568) overall percent agreement rate between three readers and a 92.8% (739/796) overall agreement rate between four readers. It has been concluded that the VENTANA CD30 (Ber-H2) Assay and the predicate DAKO K965022 device are substantially equivalent.
Key Metrics
91.0% (517-568) overall percent agreement rate between three readers.
92.8% (739/796) overall agreement rate between four readers.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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May 8, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ventana Medical Systems, Inc. Jeffrey M. Catania, Ph.D. Regulatory Affairs Director 1910 E. Innovation Park Dr. Tucson, Arizona 87555
Re: K172471
Trade/Device Name: VENTANA CD30 (Ber-H2) Assay Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DEH Dated: April 5, 2018 Received: April 6, 2018
Dear Dr. Jeffrey Catania:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Donna M. Roscoe -S 2018.05.08 15:17:03 -04'00'
For Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172471
Device Name VENTANA CD30 (Ber-H2) Assay
Indications for Use (Describe)
The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument and OptiView DAB IHC Detection Kit. CD30 positive staining may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Ventana Medical Systems, Inc.
1910 E Innovation Park Drive
Tucson, AZ 85755
(520) 887-2155 |
|----------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Jeffrey Catania |
| Date Prepared: | 04-May-2018 |
| 510(K): | K172471 |
510(k) SUMMARY
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.
This 510(k) has not yet been assigned a number.
| Device Name | Proprietary Name: VENTANA CD30 (Ber-H2) Assay | |
|---|---|---|
| Classification: 21CFR866.5550, Immunoglobulin (light chain specific) | ||
| immunological test system. | ||
| Product Code: DEH | ||
| Predicate Device | DAKO Corporation's Monoclonal Mouse Anti-Human Ki-1antigen, CD30, | |
| Clone Ber-H2 | ||
| K965022 | ||
| Device Description | The VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber- | |
| H2) antibody, detection reagents and an instrument (BenchMark ULTRA | ||
| automated staining instrument). | ||
| The VENTANA CD30 (Ber-H2) Assay is a mouse monoclonal antibody | ||
| (IgG1, kappa) directed against CD30. CD30 antigen is expressed in | ||
| mononuclear Hodgkin's cells and multinucleated Reed Sternberg cells of | ||
| Hodgkin Lymphoma as well as on anaplastic large cell lymphomas. This | ||
| antibody variably produces membranous, cytoplasmic, and Golgi staining of | ||
| both lymphoma cells and of scattered large activated B and T cells in lymph | ||
| nodes, spleen, tonsil, and thymus. | ||
| The OptiView DAB IHC Detection Kit is an indirect, biotin-free system for | ||
| detecting mouse IgG, mouse IgM, and rabbit primary antibodies. This kit is | ||
| intended to detect antigens by IHC in sections of formalin-fixed, paraffin- | ||
| embedded (FFPE) and frozen tissues that are stained on the BenchMark | ||
| ULTRA instrument (note: the VENTANA CD30 (Ber-H2) Assay will not | ||
| be recommended for use in frozen tissue). The OptiView DAB IHC | ||
| Detection Kit produces a visible dark brown precipitate (3, 3'- | ||
| Diaminobenzidine) via a horseradish peroxidase (HRP) enzymatic reaction | ||
| at the antigen site. The Pathologist evaluates the brown precipitate using | ||
| Bright-field microscopy. | ||
| Intended | ||
| Use | The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the | |
| qualitative detection of the CD30 protein in formalin-fixed, paraffin- | ||
| embedded tissue stained with a VENTANA BenchMark ULTRA instrument | ||
| and OptiView DAB IHC Detection Kit. CD30 positive staining results may | ||
| aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic | ||
| large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). | ||
| This product should be interpreted by a qualified pathologist in conjunction | ||
| with histological examination, relevant clinical information, and proper | ||
| controls. | ||
| This antibody is intended for in vitro diagnostic (IVD) use. | ||
| Summary of | ||
| the new and | ||
| predicate | ||
| devices | VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber-H2) | |
| antibody (mouse monoclonal), detection reagents and an automated staining | ||
| instrument (BenchMark ULTRA). It is intended for the qualitative detection | ||
| of CD30 by immunohistochemistry in formalin fixed, paraffin embedded | ||
| human tissue. The CD30 antigen is expressed in mononuclear Hodgkin's | ||
| cells and multinucleated Reed Sternberg cells of Hodgkin Lymphoma as | ||
| well as on anaplastic large cell lymphomas. This antibody variably produces | ||
| membranous, cytoplasmic, and Golgi staining of both lymphoma cells and | ||
| may be used to aid in the identification of classical Hodgkin lymphoma and | ||
| anaplastic large cell lymphoma. | ||
| The VENTANA CD30 (Ber-H2) Assay has been compared to a predicate | ||
| device, 'Monoclonal Mouse Anti-Human Ki-1antigen, CD30, Clone Ber- | ||
| H2' developed by DAKO Corporation, which reports a similar indication | ||
| and staining pattern. The predicate was granted 510(k) clearance by FDA in | ||
| 1992 (K965022). The intended use of the predicate, as reported in the 1992 | ||
| 510(k), states that, "Monoclonal mouse anti-human Ki-1 antigen, CD30, | ||
| Clone Ber-H2 (Ber-H2), may be used as one member of a panel of | ||
| antibodies to aid in the differential diagnosis of large anaplastic cells of | ||
| undetermined origin. This antibody stains cell membranes of most cases of | ||
| anaplastic large cell lymphomas (ALCL), often called Ki-1 lymphomas. It | ||
| also stains cell membranes and/or cytoplasm of most Hodgkin's lymphomas | ||
| The staining pattern is most often described as strong membranous and | ||
| weaker cytoplasmic, specifically paranuclear dot-positivity of the Golgi | ||
| region..." | ||
| The results of testing have been compared between VENTANA CD30 (Ber- | ||
| H2) Assay and the DAKO K965022 device through a premethod | ||
| comparison study. The results of the study show a 91.0% (517-568) overall | ||
| percent agreement rate between three readers and a 92.8% (739/796) overall | ||
| agreement rate between four readers. It has been concluded that the | ||
| VENTANA CD30 (Ber-H2) Assay and the predicate DAKO K965022 | ||
| device are substantially equivalent. | ||
| Non-clinical | ||
| performance | ||
| data | Non-clinical (analytical) performance testing has been conducted to demonstrate performance characteristics of VENTANA CD30 (Ber-H2) Assay. Method Comparison studies have demonstrated substantial equivalence to predicate device (Dako K965022). |
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| Comparison of VENTANA CD30 (Ber-H2) to Predicate Device, DAKO CD30 (Ber-H2) | ||
|---|---|---|
| Parameter | Predicate device | Proposed device |
| Proprietary Name | DAKO Corporation's Monoclonal Mouse Anti-Human Ki-1antigen, CD30, Clone Ber-H2 – K965022 | VENTANA CD30 (Ber-H2) Assay |
| FDA Classification | Class II, non-Exempt | Class II, non-Exempt |
| Intended Use | Monoclonal mouse anti-human Ki-1 antigen, CD30, Clone Ber-H2 (Ber-H2), may be used as one member of a panel of antibodies to aid in the differential diagnosis of large anaplastic cells of undetermined origin. This antibody stains cell membranes of most cases of anaplastic large cell lymphomas (ALCL), often called Ki-1 lymphomas. It also stains cell membranes and/or cytoplasm of most Hodgkin's lymphomas. Ber-H2 is a valuable aid in the assessment of cutaneous lymphoid infiltrates, particularly when large atypical cells are present. Most nonhematolymphoid neoplasms are negative with Ber-H2, although there are several significant exceptions. Membrane positivity is seen with embryonal carcinomas, and weak, diffuse cytoplasmic positivity is seen in pancreatic and salivary gland carcinomas. | |
| The staining pattern is most often described as strong membranous and weaker cytoplasmic, specifically paranuclear dot-positivity of the Golgi region. The weak, diffuse cytoplasmic staining is considered to be unexpected, non-specific labeling. It may be reduced or removed by changing the protease pretreatment of the paraffin sections and/or further dilution of the Ber-H2 antibody. | The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument. CD30 positive staining results may aid in the identification of classical Hodgkin lymphoma (cHL) and anaplastic large cell lymphoma (ALCL). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use. | |
| Comparison of VENTANA CD30 (Ber-H2) to Predicate Device, DAKO CD30 (Ber-H2) | ||
| Parameter | Predicate device | Proposed device |
| Proprietary Name | DAKO Corporation's Monoclonal | |
| Mouse Anti-Human Ki-1antigen, | ||
| CD30, Clone Ber-H2 – K965022 | VENTANA CD30 (Ber-H2) | |
| Assay | ||
| Sample | Acetone fixed, frozen and formalin or | |
| B5 fixed, paraffin-embedded tissues | Formalin fixed, paraffin | |
| embedded human tissue | ||
| Assay Method | IHC | IHC |
| Target | CD30 | CD30 |
| Assay Format | Automated | Automated |
| Detection System | Direct | Direct |
| Visualization | Interpretation by light microscopy | Interpretation by light |
| microscopy | ||
| Intended Use Population | Hodgkin's Lymphoma and Anaplastic | |
| Large Cell Lymphoma | Hodgkin's Lymphoma and | |
| Anaplastic Large Cell | ||
| Lymphoma | ||
| Qualitative or | ||
| Quantitative | Qualitative | Qualitative |
| Conclusion | VENTANA CD30 (Ber-H2) Assay is substantially equivalent to Dako's | |
| 510(k) cleared cd30 Ber-H2 clone in relevant characteristics and | ||
| performance: any differences will not adversely affect safety and efficacy. |
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