# K972382: UB Analyzer UA-2, Reagent Kit and Bilirubin Control

- Pathway: 510(k) (Traditional)
- Applicant: Arrows Co., Ltd.
- Decided: Sep 14, 1998 after 445 days
- Product code: CIG (Diazo Colorimetry, 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 K871115 (1989). 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)
- K871115: UB Analyzer, Model UA-1/Reagent Kit/Bilirubin Con., Labo Science-USA, Inc. (1989) Summary page 2.

## Indications for use
UB analyzer UA-2 and its exclusive reagent kit are designed to determine both total and unbound bilirubin concentration in neonatal serum using exclusive reagent kit, “UB TEST.” The total bilirubin and unbound bilirubin concentration in neonatal serum can be used to provide the physician with additional information in the clinical assessment of jaundiced neonates and the possible risk of bilirubin encephalopathy.

Source page: https://510kreport.com/device/K972382
Methodology: https://510kreport.com/methodology