# K040692: Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL Cholesterol Calibrator ODC0023

- Pathway: 510(k) (Special)
- Applicant: Olympus America, Inc.
- Decided: Apr 8, 2004 after 22 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K100010: HDL Cholesterol (HDLX) Assay (2010), 0 descendants of its own

## Indications for use
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K040692
Methodology: https://510kreport.com/methodology