# K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 29, 2001 after 23 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: 1 generation back to K002460 (2000). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002460: Liquichek Lipids Control, Model 641, 642, Bio-Rad (2000) Summary page 1.

## Most influential descendants
- K082067: MSC Lipid Control (2008), 1 descendant of its own
- K103271: MSC Lipid Control (2011), 0 descendants of its own
- K101226: Audit Microcv RF/CRP Linearity Set (2010), 0 descendants of its own
- K042837: Liquichek Elevated CRP Control (2004), 0 descendants of its own

## Indications for use
Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert

Source page: https://510kreport.com/device/K012513
Methodology: https://510kreport.com/methodology