510(k) · Cleared
ClearedFreelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II
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 Jul 15, 2003 after a 106-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Jul 15, 2003
- Review
- 106 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 6 citing it directly.
- This deviceK031016 Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring…The Binding Site, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK182098 N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH · 2018
- Descendant · cites it directly · 2 of its ownK171742 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard…Siemens Healthcare Diagnostics Products GmbH · 2017
- Descendant · cites it directly · 1 of its ownK201496 N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH · 2021
- Descendant · cites it directly · 1 of its ownK193047 N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH · 2021
- Descendant · cites it directly · 0 of its ownK231601 FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH · 2018 · cites it directly2descendants
- K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1…Siemens Healthcare Diagnostics Products GmbH · 2017 · cites it directly2descendants
- K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH · 2021 · cites it directly1descendant
- K193047N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH · 2021 · cites it directly1descendant
- K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031016 | Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring… | The Binding Site, Ltd. | 2003 | — |
| +1 | K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH | 2018 | — |
| +1 | K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC… | Siemens Healthcare Diagnostics Products GmbH | 2017 | — |
| +1 | K201496 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021 | — |
| +1 | K193047 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021 | — |
| +1 | K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
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 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?
The FDA summary names no predicate by number.
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | 2018 | 2 |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1… | 2017 | 2 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | 2021 | 1 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | 2021 | 1 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | 2024 | 0 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | 2022 | 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, K182098 (Siemens Healthcare Diagnostics Products GmbH, 2018) has gone furthest, with 2 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 kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of 1light chains aids in the diagnosis and monitoring of nultiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic: Jupus erythemoatosus. This kit is intended…
Read the full statement (124 words)
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of 1light chains aids in the diagnosis and monitoring of nultiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic: Jupus erythemoatosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of 1light chains aids in the diagnosis and monitoring of multiple nyeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinenia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.
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/K031016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031016: Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031016
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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