# K972287: Dade Tru-Liquid Bilirubin Control

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Jul 7, 1997 after 18 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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 K833097 (1984). 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)
- K833097: Chem Trak Liquid Bilirubin Control, Medical Analysis Systems, Inc. (1984) Summary page 1.

## Indications for use
Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision in the clinical laboratory assay of bilirubin.

Source page: https://510kreport.com/device/K972287
Methodology: https://510kreport.com/methodology