# K014018: Cholesterol 1, 2, 3

- Pathway: 510(k) (Traditional)
- Applicant: Imi
- Decided: Jun 24, 2002 after 200 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- 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
Longest line of descent: 1 generation back to K000568 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000568: HDL Cholesterol Plus, Roche Diagnostics Corp. (2000)

## Cited in the summary but kept off the family tree
- K089585: Synchron CX 8 Systems HDL Cholesterol Reagent. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Skin cholesterol as measured by Cholesterol 1,2,3TMcan be used as part of risk assessment for coronary heart disease in persons with a history of myocardial infarction and/or in persons suspected of having significant multi-vessel coronary artery disease (>50% stenosis in >1 vessel as diagnosed by coronary angiography) where further diagnostic evaluation is being considered. Test results, when considered in conjunction with clinical evaluation, blood cholesterol tests and other risk factors identified for coronary artery disease, will aid the physician in focusing diagnostic and patient management options.

Source page: https://510kreport.com/device/K014018
Methodology: https://510kreport.com/methodology