# K050823: Direct HDL Cholesterol and Direct HDL/LDL Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Jul 26, 2005 after 117 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.
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
- K122126: Direct LDL/HDL Cholesterol Calibrator (2012), 0 descendants of its own

## Indications for use
TecoDirect HDULDL Calibrator for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K050823
Methodology: https://510kreport.com/methodology