# K030074: Linical Immunology Calibration Verifiers Levels a-E for Beckman Coulter Synchron CX Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Jan 21, 2003 after 13 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
LiniCALTMImmunology Calibration Verifiers Levels A - E for Beckman Coulter Synchron CX@Systems are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron CX@Systems, Five assayed levels are provided for IgA, IgG, IgM, TRF, AS0 and PA6 to allow monitoring of the reportable range.

Source page: https://510kreport.com/device/K030074
Methodology: https://510kreport.com/methodology