# K992939: Qualitrol Immunoassay Plus Control, Levels 1,2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Seracare Technology
- Decided: Dec 9, 1999 after 100 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K020237: Immunoassay Plus Control, Levels 1, 2, and 3 (2002), 1 descendant of its own
- K033344: Ligand Plus Control Level 1-3 (2004), 0 descendants of its own

## Indications for use
QUALITROL 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/K992939
Methodology: https://510kreport.com/methodology