# K172471: VENTANA CD30 (Ber-H2) RxDx Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: May 8, 2018 after 266 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: 2 generations back to K896918 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965022: Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code NO. MO751), Dako Corp. (1997) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K172471
Methodology: https://510kreport.com/methodology