510(k) · Cleared
ClearedKappa Light Chains
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SENTINEL CH. SpA · DFH Kappa, Antigen, Antiserum, Control
Cleared on Sep 3, 2009 as substantially equivalent to K964260 (Beckman Instruments, Inc., 1997) after a 272-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Sep 3, 2009
- Review
- 272 days
- Class
- Class II
- Product code
- DFH
- 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) | K083602 | Kappa 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 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? (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 3 of 5 Substantial Equivalence: The Kappa light chains assay is substantially equivalent to Beckman IMMAGE Immunochemistry System Kappa light chain (K964260) on the IMMAGE nephelometer Analyzer. Both assays yield similar Performance Characteristics. Similarities: · Bo… | 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 12.6 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 DFH devicesDFH Kappa, 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 · 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?
The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. Measurement of type of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), 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/K083602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083602: Kappa Light Chains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083602
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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