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UB Analyzer UA-2, Reagent Kit and Bilirubin Control

by Arrows Co., Ltd. 510(k)

Active United States

510(k) K972382

Overview

The UB Analyzer UA-2 is a Diazo Colorimetry, Bilirubin device designed for in vitro diagnostic use. It measures total and unbound bilirubin concentrations in neonatal serum, enabling clinical assessment of jaundice and potential bilirubin encephalopathy risk.

This system comprises an analyzer, reagent kit, and bilirubin control, intended for single-use in clinical chemistry settings. Supplied as a Class II device under FDA 510(k) clearance (K972382), it adheres to regulatory requirements for in vitro diagnostics. No MRI safety or sterility specifications are noted in the data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972382 Date14 Sep 1998ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
CIG
Device Class
Class II
Regulation
21 CFR Part 862.1110
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Questions

  • What clinical conditions does the UB Analyzer UA-2 help assess in newborns?

    The UB Analyzer UA-2 measures total and unbound bilirubin concentrations in neonatal serum, which helps clinicians evaluate jaundice and assess the risk of bilirubin encephalopathy—a serious condition caused by high bilirubin levels in infants.

  • Is the UB Analyzer UA-2 intended for single-use or repeated use in a clinical setting?

    The UB Analyzer UA-2 is explicitly designed for single-use in clinical chemistry settings, as stated in its description. This means each system (analyzer, reagent kit, and bilirubin control) is meant to be used once before disposal.

  • How is the UB Analyzer UA-2 regulated, and what does that mean for its use?

    The UB Analyzer UA-2 is classified as a Class II medical device under FDA 510(k) clearance (K972382) and is intended for in vitro diagnostic use. This means it has undergone regulatory review to ensure its safety and performance for measuring bilirubin levels, but it does not imply any specific sterilization or MRI safety requirements.

  • What type of testing method does the UB Analyzer UA-2 use to measure bilirubin?

    The UB Analyzer UA-2 employs Diazo Colorimetry, a chemical method that detects bilirubin levels by reacting with reagents to produce a color change proportional to bilirubin concentration. This allows for precise measurement of both total and unbound bilirubin in neonatal serum.

  • Does the UB Analyzer UA-2 come with any built-in quality controls, and if so, what are they?

    Yes, the UB Analyzer UA-2 includes a bilirubin control as part of its system. This control helps ensure the accuracy and reliability of the measurements by providing a reference standard for bilirubin levels, allowing clinicians to verify the performance of the device before use.