# K032035: Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 7, 2003 after 37 days
- Product code: CZW (Complement C3, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771603 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964842: Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent, Beckman Instruments, Inc. (1997) Summary page 1.
- K771603: Immochemistry System, Beckman Instruments, Inc. (1977) Summary page 1.
- K791341: Human Alpha, Acid Glycoprotein, Beckman Instruments, Inc. (1979) Summary page 1.

## Indications for use
C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry. C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry. The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.

Source page: https://510kreport.com/device/K032035
Methodology: https://510kreport.com/methodology