# K100550: Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: Sep 28, 2010 after 214 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Poly-Chem 90 Direct HDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure high density lipoproteins quantitatively in human serum on the Poly-Chem 90 analyzer. HDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease. The Poly-Chem 90 Direct LDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure low density lipoprotens quantitatively in human serum on the Poly-Chem 90 analyzer. LDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease. The Poly-Chem 90 Cholesterol test system is an in vitro diagnostic procedure intended to measure cholesterol quantitatively in human serum on the Poly-Chem 90 analyzer. Cholesterol measurements are used in the diagnosis and treatment of lipid disorders, lipoprotein metabolism disorders and atherosclerosis. The Poly-Chem 90 Triglycerides test system is an in vitro diagnostic procedure intended to measure triglyceride quantitatively in human serum on the Poly-Chem 90 analyzer. Triglycerides measurements are used in the diagnosis and treatment of disease involving lipid metabolism and various endocrine disorders e.g. diabetes mellitus, nephrosis and liver obstruction.

Source page: https://510kreport.com/device/K100550
Methodology: https://510kreport.com/methodology