# K103271: MSC Lipid Control

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Jan 25, 2011 after 81 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: 3 generations back to K002460 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K082067: MSC Lipid Control, Maine Standards Co. (2008) Summary page 1.

## Indications for use
The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B), on instruments listed in the value sheet.

Source page: https://510kreport.com/device/K103271
Methodology: https://510kreport.com/methodology