# K014103: Synchron Systems Direct LDL Chloesterol Reagent and Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 28, 2002 after 46 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K971573 (1997). 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)
- K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set, Genzyme Corp. (1997) Summary page 1.

## Recalls of this device
- Feb 10, 2003 · Not classified · Z-1099-04: Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

## Indications for use
The SYNCHRON® Systems Direct LDL Cholesterol (LDLD) Reagent, when used in conjunction with SYNCHRON® Systems LDLD Calibrator, is intended for the quantitative determination of low density lipoprotein cholesterol in serum and plasma on Beckman Coulter’s SYNCHRON Systems by colarimetry. LDL cholesterol is directly related to the risk of developing coronary heart disease. A low HDL/LDL cholesterol ratio is directly related to the risk of developing coronary artery disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering 1:herapy.1 1. “Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detectlian, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel [11)", JAMA, 285:2486 (2001).

Source page: https://510kreport.com/device/K014103
Methodology: https://510kreport.com/methodology