510(k) · Cleared
Recalled · Class II · 2022The Helena V8 Immunodisplacement Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helena Laboratories Uk, Ltd. · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Jun 26, 2012 after a 407-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jun 26, 2012
- Review
- 407 days
- Class
- Class II
- Product code
- CFF
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2022 | Class II | Z-1244-2022 | Unknown/Undetermined by firm | Due to microbial growth causing interference with interpretation. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CFF devicesCFF Immunoelectrophoretic, Immunoglobulins, (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CFF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CFF
Too few CFF 510(k)s in any year since 2007 to give a median.
Recalls per year · CFF
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFF
1in 2021
MAUDE reports naming product code CFF, 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 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's lgG, IgA, 1gM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins…
Read the full statement (109 words)
The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's lgG, IgA, 1gM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera. are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests.
For In Vitro Diagnostic Use Only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111369: The Helena V8 Immunodisplacement Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111369
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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