# K020575: Atac Direct LDL Reagent and Atac Direct LDL Calibrator Kits

- Pathway: 510(k) (Traditional)
- Applicant: Elan Diagnostics
- Decided: Apr 12, 2002 after 50 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- 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. The FDA summary names its predicate without a number.
- (no number) N-geneous LDL Cholesterol Reagent Kit and N-geneous LDL Cholesterol Calibrator: named in the summary without a submission number

## Indications for use
The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K020575
Methodology: https://510kreport.com/methodology