# K082067: MSC Lipid Control

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Aug 22, 2008 after 31 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002460 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642, Bio-Rad (2001) Summary page 1.

## Most influential descendants
- K103271: MSC Lipid Control (2011), 0 descendants of its own

## Indications for use
The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.

Source page: https://510kreport.com/device/K082067
Methodology: https://510kreport.com/methodology