# K980650: Rep Cholesterol Profile Template-30, -16, -8; Rep Vis Cholesterol

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: May 1, 1998 after 71 days
- Product code: JHO (Electrophoretic Separation, Lipoproteins)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Cholesterol test system is useful in monitoring LDL and HDL cholesterol levels. Patients at risk include males over 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patients’ number of risk factors, treatment can be medication or diet restrictions.

Source page: https://510kreport.com/device/K980650
Methodology: https://510kreport.com/methodology