# K013152: Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator Kits

- Pathway: 510(k) (Traditional)
- Applicant: Elan Holdings, Inc.
- Decided: Nov 9, 2001 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.
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) Roche HDL-Cholesterol plus Reagent Kit, product no. 1930672: named in the summary without a submission number
- (no number) Roche C.f.a.s HDL/LDL-C plus calibrator, product no. 1972235: named in the summary without a submission number

## Indications for use
The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (suchras 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/K013152
Methodology: https://510kreport.com/methodology