# K963543: Sigma Diagnostics CX -3 Calibration Standard, Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Oct 30, 1996 after 56 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. The FDA summary names its predicate without a number.
- (no number) Beckman Calibration Standard 2, Part No. 443365: named in the summary without a submission number

## Indications for use
Sigma Diagnostics CX®3 Calibration Standard Level 2 is used to calibrate the Beckman SYNCHRON CX®3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasm, urine, or cerebrospinal fluid. Calibration Standard Level 2 should be used with CX®3 Calibration Standard Level 1.

Source page: https://510kreport.com/device/K963543
Methodology: https://510kreport.com/methodology