# K070971: Modification to Sentinel Clin Chem Cal

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: May 23, 2007 after 47 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 K051452 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051452: Sentinel Clin Chem Cal, Sentinel Ch. Srl (2005) Summary page 1.

## Indications for use
Clinical Chemistry - The Sentinel Clin Chem Cal is a device intended for medical purposes for use in Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" assays to establish points of reference that are used in the determination of values in the measurement of Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" in human specimens.

Source page: https://510kreport.com/device/K070971
Methodology: https://510kreport.com/methodology