# K033344: Ligand Plus Control Level 1-3

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technology
- Decided: Jan 16, 2004 after 88 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 K992939 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020237: Immunoassay Plus Control, Levels 1, 2, and 3, Consolidated Technology (2002) Summary page 1.

## Indications for use
LIGAND PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.

Source page: https://510kreport.com/device/K033344
Methodology: https://510kreport.com/methodology