# K081533: Sentinel Plasmaproteins Cal 3X

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Jun 25, 2008 after 23 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011226 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051457: Sentinel Plasmaproteins Cal 3X, Sentinel Ch. Srl (2005) Summary page 2.
- K011226: Calibrator for Automated Systems, Roche Diagnostics Corp. (2001)

## Indications for use
Clinical Chemistry - The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma.

Source page: https://510kreport.com/device/K081533
Methodology: https://510kreport.com/methodology