# K965108: Synchron LX Systems Immunoglobulin G/a/M Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 6, 1997 after 76 days
- Product code: DEW (Igg, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771603 (1977). 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)
- K771603: Immochemistry System, Beckman Instruments, Inc. (1977) Summary page 1.

## Recalls of this device
- Mar 11, 2011 · Not classified · Z-2226-2011: The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation 
- Jun 28, 2010 · Not classified · Z-2653-2010: The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reagent lots M812164 or M

## Indications for use
The SYNCHRON LX Systems immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Immunogiobulin M (ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

Source page: https://510kreport.com/device/K965108
Methodology: https://510kreport.com/methodology