# K051452: Sentinel Clin Chem Cal

- Pathway: 510(k) (Abbreviated)
- Applicant: Sentinel Ch. Srl
- Decided: Oct 25, 2005 after 145 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
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 its predicate without a number.
- (no number) Roche Clin Chem Cal REF 16550: named in the summary without a submission number

## Most influential descendants
- K070971: Modification to Sentinel Clin Chem Cal (2007), 0 descendants of its own

## Indications for use
Clinical Chemistry - The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.

Source page: https://510kreport.com/device/K051452
Methodology: https://510kreport.com/methodology