# K980646: IL Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole Blood Samples

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 6, 1998 after 76 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: 1 generation back to K832236 (1983). 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)
- K832236: Sigma Procedure #550 Determ. Bilirub, Sigma Chemical Co. (1983) Summary page 1.

## Indications for use
The IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates. Elevated bilirubin levels in the blood of newborns is used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Source page: https://510kreport.com/device/K980646
Methodology: https://510kreport.com/methodology