# K971283: Synchron Systems Cal 5 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jun 3, 1997 after 57 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
Longest line of descent: 1 generation back to K926236 (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)
- K926236: Beckman Anti-Streptolysin O Kit, Beckman Instruments, Inc. (1993) Summary page 1.

## Indications for use
The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the calibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.

Source page: https://510kreport.com/device/K971283
Methodology: https://510kreport.com/methodology