# K040174: Bilirubin Assay on the Omni S Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 14, 2004 after 109 days
- Product code: MQM (Bilirubin (Total And Unbound) In The Neonate Test System)
- Device class: 1
- Regulation: 21 CFR 862.1113
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K952621 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981632: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent, Roche Diagnostics/Boehringer Mannheim GmbH (1998) Summary page 1.
- K991417: Abl 735 Analyzer, Radiometer America, Inc. (1999) Summary page 1.
- K011213: Modification to Synchron LX 20 Clinical Chemistry System, Beckman Coulter, Inc. (2001)
- K840880: Ektachem Clinical Chem. Slides, Eastman Kodak Company (1984) Summary page 1.

## Indications for use
The Roche Diagnostics OMNI S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, P02, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

Source page: https://510kreport.com/device/K040174
Methodology: https://510kreport.com/methodology