# K013235: Modification to Synchron Control

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 16, 2001 after 18 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003488 (2000). 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)
- K003488: Synchron Control, Beckman Coulter, Inc. (2000) Summary page 2.

## Recalls of this device
- Apr 1, 2003 · Not classified · Z-1151-04: The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were highe

## Indications for use
SYNCHRON® Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other: Level 2 is manufactured by combining equal quantities of levels 1 and 3. The use of three levels enable the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision.

Source page: https://510kreport.com/device/K013235
Methodology: https://510kreport.com/methodology