# K983134: NBIL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 23, 1998 after 15 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 K880743 (1988). 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)
- K880743: Abbott a-Gent Neonatal Bilirubin Reagent, Abbott Laboratories (1988) Summary page 1.

## Indications for use
The Neonatal Bilirubin assay is used for the quantitation of bilirubin in human neonate serum or plasma. Measurements of bilirubin (total and unbound) in newborn infants are used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Source page: https://510kreport.com/device/K983134
Methodology: https://510kreport.com/methodology