# K083601: Lambda Light Chains

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Jun 22, 2009 after 199 days
- Product code: DEH (Lambda, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884276 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964260: Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry System Lamda Light Chain (Lam) Reag, Beckman Instruments, Inc. (1997) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K083601
Methodology: https://510kreport.com/methodology