# K992770: Qualitrol Immunology Control, Level 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Seracare Technology
- Decided: Nov 12, 1999 after 87 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 K945651 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945651: Liquichek (TM Immunology Control, Levels 1.2. and 3, Bio-Rad (1995) Summary page 1.

## Indications for use
Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.

Source page: https://510kreport.com/device/K992770
Methodology: https://510kreport.com/methodology