# K992971: Rep Cholesterol Profile Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Oct 18, 1999 after 45 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 Cholestercl Profile test system is useful in monitoring LDL, HDL, VLDL and Lp(a)=-C cholestercl when present in concentrations greater than 2.5 mg/dL. However in some patients Lp(a)—-C may not be present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and femalas over S5 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient’s number of risk factors, treatment can be medication or diet restrictions.

Source page: https://510kreport.com/device/K992971
Methodology: https://510kreport.com/methodology