# K971905: Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Dec 12, 1997 after 203 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 K864893 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864893: Anti-Cytokeratin Monoclonal Antibody, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 1.

## Indications for use
Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BE12 Antibody may be used as one member of a panel of antibodies to aid in the differential diagnosis of anaplastic cells of undetermined origin. When used with markers of simple epithelium, it can aid in the differentiation of carcinomas from non epithelial tumors, e.g., gliomas, lymphomas, melanomas, sarcomas or seminomas. Because it does not react with all carcinomas, it may be used also as an aid in the subclassification of carcinomas. It is also useful in the differential diagnosis of small-acinar lesions of the prostate gland because it stains basal cells which are absent in this disease. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient’s clinical history and other diagnostic tests by a qualified individual having knowledge of all the potential antibody reactivities.

Source page: https://510kreport.com/device/K971905
Methodology: https://510kreport.com/methodology