# K991083: RLP Cholesterol Immunoseparation Assay

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka Pharmaceutical Co., Ltd.
- Decided: Aug 20, 1999 after 142 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
Longest line of descent: 1 generation back to K833611 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833611: Titan Gel Lipoprotein Electrophoresis, Helena Laboratories (1984) Summary page 2.
- K935162: Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit, Helena Laboratories (1994) Summary page 2.

## Indications for use
The RLP-Cholesterol Assay is intended for use in the quantitative determination of cholesterol contained in remnant lipoproteins in human serum or plasma. The test results are used in combination with total serum triglyceride measurements to aids in the diagnosis of familial type III hyperlipoproteinemia in patients with serum total cholesterol concentration > 200 mg/dL and triglyceride concentrations between 200 and 800 mg/dL.

Source page: https://510kreport.com/device/K991083
Methodology: https://510kreport.com/methodology