# K110251: Synchron Multi Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 25, 2011 after 117 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 its predicate without a number.
- (no number) SYNCHRON Multi Calibrator: named in the summary without a submission number

## Most influential descendants
- K112834: Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles (2012), 0 descendants of its own

## Recalls of this device
- Dec 15, 2011 · Class III · Z-0110-2013: The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent C

## Indications for use
The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid.

Source page: https://510kreport.com/device/K110251
Methodology: https://510kreport.com/methodology