# K051457: Sentinel Plasmaproteins Cal 3X

- Pathway: 510(k) (Abbreviated)
- Applicant: Sentinel Ch. Srl
- Decided: Jul 25, 2005 after 53 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081533: Sentinel Plasmaproteins Cal 3X (2008), 0 descendants of its own

## Recalls of this device
- Jun 1, 2012 · Class II · Z-0256-2013: There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lo

## Indications for use
The Sentinel Plasmaproteins Cal 3x is a device intended for medical purpose for use in ceruloplasmin, kappa light chains and lambda light chains assay to establish points of reference that are used in the determination of values in the measurement of ceruloplasmin, kappa and lambda light chains in human serum and plasma.

Source page: https://510kreport.com/device/K051457
Methodology: https://510kreport.com/methodology