# K981345: Cholestron Pro II Cholesterol Test

- Pathway: 510(k) (Traditional)
- Applicant: Lifestream Diagnostics, Inc.
- Decided: Oct 1, 1998 after 170 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. The FDA summary names its predicate without a number.
- (no number) Accu-Chek® InstantPlus™ Cholesterol Test (also known as Accutrend GC Test): named in the summary without a submission number

## Indications for use
Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and aid in the management of patients undergoing therapy with lipid lowering drugs.

Source page: https://510kreport.com/device/K981345
Methodology: https://510kreport.com/methodology