# K980770: HDL Uni-Paks (Pta), Catalogue Number 215-51

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Apr 21, 1998 after 60 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
Foe the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use. Barr, et.al. (1) in 1951 first reported the inverse relationship between high density lipoproteins (HDL) and coronary heart disease. Since that time, several procedures have been used to separate HDL including ultracentrifugation, electrophoresis, and precipitation. With the precipitation methods (heparin/manganese, dextran sulfate/magnesium, phosphotungstate/magnesium, and polyethylene glycol), the very low density lipoproteins (VLDL) and the low density lipoproteins (LDL) are first selectively precipitated and then the supernatant containing HDL is removed. Cholesterol concentration in the supernatant is then assayed to determine HDL-Cholestcrol concentration using an enzymatic total cholesterol procedure. The procedure for HDL-Cholesterol precipitation in this formulation is a modification of the Burnstein and Samaille (2) method and uses phosphotungstate and magnesium ions to precipitate the LDL and VLDL f(ractions.

Source page: https://510kreport.com/device/K980770
Methodology: https://510kreport.com/methodology