# K020237: Immunoassay Plus Control, Levels 1, 2, and 3

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technology
- Decided: Mar 19, 2002 after 55 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 K992939 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992939: Qualitrol Immunoassay Plus Control, Levels 1,2 and 3, Seracare Technology (1999) Summary page 1.

## Most influential descendants
- K033344: Ligand Plus Control Level 1-3 (2004), 0 descendants of its own

## Indications for use
IMMUNOASSAY 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 theraputic drugs as listed in this package insert.

Source page: https://510kreport.com/device/K020237
Methodology: https://510kreport.com/methodology