510(k) · Cleared
ClearedFreelite Human Kappa and Lambda Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · DFH Kappa, Antigen, Antiserum, Control
Cleared on Mar 11, 2004 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 11, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- DFH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK040009 Freelite Human Kappa and Lambda KitsThe Binding Site, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK250549 Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda…The Binding Site Group, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK173732 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda…The Binding Site Group, Ltd. · 2018 · Recalled
- 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 3 of 3 · See all- K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group, Ltd. · 2025 · cites it directly0descendants
- K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group, Ltd. · 2018 · cites it directly0descendants
- 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) | K040009 | Freelite Human Kappa and Lambda Kits | The Binding Site, Ltd. | 2004 | — |
| +1 | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group, Ltd. | 2025 | — |
| +1 | K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group, Ltd. | 2018 | 1 |
| +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 |
| 2018 | 1 | 0 |
| 2025 | 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 DFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DFH device
- #1 K253358 Diazyme Human Kappa (k) Free Light Chain…score 10.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | 2025 | 0 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | 2018 | 0 |
| 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, K250549 (The Binding Site Group, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DFH devicesDFH Kappa, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DFH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFH
340in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DFH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFH
10in 2025
MAUDE reports naming product code DFH, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 4 | 340 | 0 | 11 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelorneter II (BNTMII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus. This kit is intended…
Read the full statement (364 words)
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelorneter II (BNTMII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelorneter II (BNlTMI). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Beckman Coulter IMMAGETM. Measurement of the various amounts of the different types of light chains aids ir the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Beckman Coulter IMMAGETM. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Hitachi 911/912/917/Modular P. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Hitachi 911/912/917/Modular P. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040009: Freelite Human Kappa and Lambda Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040009
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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