# K053090: Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 16, 2005 after 44 days
- Product code: JFM (Enzymatic Method, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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 K791141 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843174: Dri-Stat Enzymatic Bilirubin Test Kit, Beckman Instruments, Inc. (1984) Summary page 1.
- K791141: Bilirubin Calibrator Control, Beckman Instruments, Inc. (1979) Summary page 1.

## Indications for use
Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems. Measurements of total bilirubin in serum and plasma are used in the diagnosis of hemolytic disorder, biliary obstruction, hepatitis and cirrhosis

Source page: https://510kreport.com/device/K053090
Methodology: https://510kreport.com/methodology