# K041975: Validate Lipoprotein Calibration Verification Test Set, Model 501

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Oct 15, 2004 after 85 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 K863751 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012120: Validate Chem 4 Calibration Verification Test Set, Model 10004, Maine Standards Co. (2001) Summary page 1.

## Indications for use
The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A, and Apolipoprotein B.

Source page: https://510kreport.com/device/K041975
Methodology: https://510kreport.com/methodology