# K965022: Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code NO. MO751)

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Nov 6, 1997 after 325 days
- Product code: DEH (Lambda, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896918 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896918: Mouse Anti-Human Leucocyte Antigen & Dako Pap Kit, Dako Corp. (1990) Summary page 1.

## Most influential descendants
- K172471: VENTANA CD30 (Ber-H2) RxDx Assay (2018), 0 descendants of its own

## Indications for 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 nonhcmatolymphoid neoplasms are negative with Ber-H2, although there are scveral 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 cytoplasinic, specifically paranuclcar 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 protcasc pretreatment of the paraffin sections and/or further dilution of the Ber-H2 antibody.

Source page: https://510kreport.com/device/K965022
Methodology: https://510kreport.com/methodology