# K980525: Ubas Manual Method and Ubas Automated Method

- Pathway: 510(k) (Traditional)
- Applicant: Marukin Shoyu Co., Ltd.
- Decided: Apr 15, 1998 after 63 days
- Product code: KWX (Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids)
- Device class: 2
- Regulation: 21 CFR 862.1187
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Marukin Shoyu Co., Lid's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.

Source page: https://510kreport.com/device/K980525
Methodology: https://510kreport.com/methodology