510(k) · Cleared
ClearedChemmate Kappa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Cleared on Oct 3, 1997 after an 85-day review. The FDA summary names no predicate by number.
- Decided
- Oct 3, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- DEM
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 DEM? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All DEM devicesDEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DEM
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DEM
Too few DEM 510(k)s in any year since 2007 to give a median.
Recalls per year · DEM
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEM
1in 2024
MAUDE reports naming product code DEM, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To qualitatively aid in the identification by light microscopy of human cells of lymphoid origin, by recognizing kappa light chains in immunoglobulin secreting plasma cells and plasmacytoid B lymphocytes, in normal and pathologic paraffin embedded tissues processed in neutral buffered formalin, B5, or Bouin's fixative. Positive results aid in the differential diagnosis, classification and immunophenotyping of lymphomas and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphological criteria and multiple chemical and immunohistochemical stains.
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/K973391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973391: Chemmate Kappa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026