510(k) · Cleared
ClearedDako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako Corp. · DEH Lambda, Antigen, Antiserum, Control
Cleared on Dec 12, 1997 as substantially equivalent to K864893 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1988) after a 203-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Dec 12, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864893 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK864893 Anti-Cytokeratin Monoclonal AntibodyBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- This deviceK971905 Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone…Dako Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864893 | Anti-Cytokeratin Monoclonal Antibody | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| 0 (this device) | K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12… | Dako Corp. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K864893 | Anti-Cytokeratin Monoclonal AntibodySummary page 1…evice classification is under the Hematology and Pathology devices panel. Division of Clinical Laboratory Devices. Becton Dickinson Anti-Human Cytokeratin, CAMS5.2 (FDA K864893). 1) Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34BE12 (Product Code No. M0630) is a mouse anti-huma… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DEH devicesDEH Lambda, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DEH
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DEH
Too few DEH 510(k)s in any year since 2007 to give a median.
Recalls per year · DEH
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEH
11in 2025
MAUDE reports naming product code DEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 2 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (155 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971905: Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026