# K994438: Bilichek Non-Invasive Bilirubin Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Spectrx, Inc.
- Decided: Feb 4, 2000 after 36 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: 2 generations back to K922770 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983071: Bilichek Non-Invasive Bilirubin Analyzer, Respironics, Inc. (1999) Summary page 1.
- K964590: Colormate Iii, Chromatics Color Sciences Intl., Inc. (1997) Summary page 1.
- K922770: Unistat Bilirubinometer Models 10310 and 10311, Leica, Inc. (1992) Summary page 1.

## Indications for use
The BiliChek Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromatography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

Source page: https://510kreport.com/device/K994438
Methodology: https://510kreport.com/methodology