# K023784: Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira Anaylzer

- Pathway: 510(k) (Special)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Dec 24, 2002 after 42 days
- Product code: LBR (Ldl & Vldl Precipitation, 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
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
Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROLa HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be usefui in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K023784
Methodology: https://510kreport.com/methodology