# K993546: Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Nov 30, 1999 after 42 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Tri-Point™ ., Liqguimmune® Liquid Assayed Immunoassay Control is a human serum based quality control material intended for use as a consistent test sample of known concentration for monitoring assay conditions in immunological determinations. The user can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

Source page: https://510kreport.com/device/K993546
Methodology: https://510kreport.com/methodology