# K022519: LDL Cholesterol (Automated)

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Sep 30, 2002 after 62 days
- Product code: JHM (Colorimetric Method, Lipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 28, 2012 · Class II · Z-0977-2013: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

## Indications for use
Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

Source page: https://510kreport.com/device/K022519
Methodology: https://510kreport.com/methodology