# K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Dec 30, 2005 after 52 days
- Product code: JFM (Enzymatic Method, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912024 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970986: Wako Direct Bilirubin V, Wako Chemicals USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K223078: Atellica® CH Diazo Direct Bilirubin (D_DBil) (2023), 0 descendants of its own
- K152343: Direct Bilirubin (2016), 0 descendants of its own

## Recalls of this device
- Feb 13, 2020 · Class II · Z-1536-2020: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
- Feb 13, 2020 · Class II · Z-1538-2020: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

## Indications for use
Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

Source page: https://510kreport.com/device/K053132
Methodology: https://510kreport.com/methodology