# K033899: Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor

- Pathway: 510(k) (Special)
- Applicant: Lifestream Technologies, Inc.
- Decided: May 20, 2004 after 155 days
- Product code: NFX (Test, Cholesterol, Total, Over The Counter)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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 Lifestream Cholesterol Monitor is an over-the-counter in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples. Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and provide information for individuals who are attempting to lower their levels through diet and exercise, or who are under a physician's care with lipid lowering drugs.

Source page: https://510kreport.com/device/K033899
Methodology: https://510kreport.com/methodology