# K042195: Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 16, 2004 after 34 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936184 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040767: Synchron Systems HDL Cholesterol (HDLD) Reagent, Beckman Coulter, Inc. (2004) Summary page 1.
- K983640: Synchron Systems Lipid Calibrator, Beckman Coulter, Inc. (1998) Summary page 1.

## Indications for use
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma. The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.

Source page: https://510kreport.com/device/K042195
Methodology: https://510kreport.com/methodology