510(k) · Cleared
ClearedLambda Light Chains
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SENTINEL CH. SpA · DEH Lambda, Antigen, Antiserum, Control
Cleared on Jun 22, 2009 as substantially equivalent to K964260 (Beckman Instruments, Inc., 1997) after a 199-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jun 22, 2009
- Review
- 199 days
- Class
- Class II
- Product code
- DEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884276 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884276 | Beckman Kappa Light Chain Reagent | Beckman Instruments, Inc. | 1988 | — |
| −1 | K964260 | Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage… | Beckman Instruments, Inc. | 1997 | — |
| 0 (this device) | K083601 | Lambda Light Chains | SENTINEL CH. SpA | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964260 | Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry…Summary page 2…Page 2 of 4 Substantial Equivalence: The Lambda light chains assay is substantially equivalent to Beckman IMMAGE Immunochemistry System Lambda light chain (K964260) on the IMMAGE nephelometer Analyzer. Both assays yield similar Performance Characteristics. Similarities:… | 1997 |
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.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K964260.
How does its category compare?
All DEH devicesDEH Lambda, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of various amounts of the different types of light chains aids in the diagnosis of multiple myeloma, lymphocytic neoplasms…
Read the full statement (99 words)
The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of various amounts of the different types of light chains aids in the diagnosis of multiple myeloma, lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins) and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus in conjunction with other clinical and laboratory findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083601: Lambda Light Chains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083601
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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