# K993096: Privalink Software Accessory to the Lifestream Cholesterol Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Lifestream Technologies, Inc.
- Decided: Dec 20, 1999 after 206 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- 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
Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs. The measurement range for the Cholestron is 150 - 300 mg/dL.

Source page: https://510kreport.com/device/K993096
Methodology: https://510kreport.com/methodology