510(k) · Cleared
ClearedFreelite Human Lambda Free Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · DEH Lambda, Antigen, Antiserum, Control
Cleared on Jan 21, 2003 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 21, 2003
- Review
- 134 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023131 Freelite Human Lambda Free KitThe Binding Site, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK153394 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda…Diazyme Laboratories · 2016
Most influential descendants
Showing 1 of 1 · See all- K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay…Diazyme Laboratories · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023131 | Freelite Human Lambda Free Kit | The Binding Site, Ltd. | 2003 | — |
| +1 | K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light… | Diazyme Laboratories | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay… | 2016 | 0 |
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?
- Of its descendants, K153394 (Diazyme Laboratories, 2016) has gone furthest, with 0 descendants of its own.
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?
This kit is intended for the quantitation of
lambda free light chains in serum and urine on the Roche Hitachi
911 and Hitachi 912. Measurement of the various amounts of the
different types of light chains aids in the diagnosis and
monitoring of multiple myelomas, lymphocytic neoplasms,
Waldenstrom's macroglobulinemia and connective tissue diseases,
such as systemic lupus erythematosus.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023131 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023131: Freelite Human Lambda Free Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023131
Report an extraction error
Are you the manufacturer?
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