# K141728: Ace Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: SENTINEL CH. SpA
- Decided: Jul 28, 2014 after 32 days
- Product code: JIT (Calibrator, Secondary)
- 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 K930477 (1993). 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)
- K930477: Acs Angiotensin Converting Enzyme (Ace) Calibrator, Analytical Control Systems, Inc. (1993) Summary page 1.

## Indications for use
The ACE Calibrator is a device intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensin conventing enzyme (ACE) assay in human serum or plasma. The product is for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K141728
Methodology: https://510kreport.com/methodology