# K972070: Nichols Advantage Chemiluminescence Tri-Level Specialty Controls

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Jun 26, 1997 after 23 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K052308: Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom (2006), 0 descendants of its own

## Indications for use
The Nichols Advantage Chemiluminescence Tri-Level Specialty Controls is intended for use an assayed quality control serum to monitor the accuracy and precision of the Nichols Advantage immunoassays

Source page: https://510kreport.com/device/K972070
Methodology: https://510kreport.com/methodology