510(k) · Cleared
ClearedOptilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · PDE Immunoglobulin M Kappa Heavy And Light Chain Combined
Cleared on Dec 18, 2015 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 18, 2015
- Review
- 116 days
- Class
- Class II
- Product code
- PDE
- Recalls
- None
- 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.
Planning a device in PDE? 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?
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PDE devicesPDE Immunoglobulin M Kappa Heavy And Light Chain Combined: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PDE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PDE
Too few PDE 510(k)s in any year since 2007 to give a median.
Recalls per year · PDE
No recall names PDE since 2007.
Adverse event reports per year · PDE
No MAUDE report names PDE since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined 1 heavy and « light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenstrom’s macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of…
Read the full statement (146 words)
The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined 1 heavy and « light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenstrom’s macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrém’s macroglobulinaemia. The Optilite Hevylite IgM Lambda Kit is intended for the quantitative in vitro measurement of IgM lambda (combined p heavy and A light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenstrom’s macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstrom’s macroglobulinaemia.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152389: Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152389
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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