# K972041: EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5)

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Jul 22, 1997 after 50 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method: named in the summary without a submission number

## Most influential descendants
- K012221: Safe at Home Cholesterol Profile Blood Collection and Transport System (2002), 1 descendant of its own
- K063852: Accessa Cholesterol Panel (2007), 0 descendants of its own
- K011970: Biosafe Cholesterol Profile Blood Collection and Transport System (2001), 0 descendants of its own

## Indications for use
Sigma Diagnostics EZ HDL™ Reagent (Procedure 354) is a device intended to measure HDL cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intended for medical purposes for use in a HDL cholesterol test system to establish points of reference that are used in the determination of values in the measurement of HDL cholesterol in human specimens.

Source page: https://510kreport.com/device/K972041
Methodology: https://510kreport.com/methodology