# K073537: Neonatal Bilirubin on Rapidlab Models 1245 and 1265

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Jun 27, 2008 after 193 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K861087 (1986). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043218: ABL800 Flex with Flexq Module, Model ABL8XX, Radiometer Medical Aps (2005) Summary page 1.
- K991417: Abl 735 Analyzer, Radiometer America, Inc. (1999) Summary page 1.

## Most influential descendants
- K110277: Rapidpoint 405 Neonatal Bilirubin (2011), 0 descendants of its own

## Recalls of this device
- Aug 11, 2016 · Class II · Z-2802-2016: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- Aug 11, 2016 · Class II · Z-2803-2016: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- May 6, 2015 · Class II · Z-1962-2015: D50 and D51 diagnostic error codes are not functional.
- Dec 30, 2014 · Class II · Z-1254-2015: Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 2
- Dec 30, 2014 · Class II · Z-1255-2015: Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 2
- Sep 17, 2012 · Class II · Z-0107-2014: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misiden
- Sep 17, 2012 · Class II · Z-0108-2014: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misiden

## Indications for use
The neonatal bilirubin test intended use on the Rapidlab 1245 and Rapidlab 1265 analyzers is an in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants. Measurement of nBili aids in assessing the risk of kernicterus.

Source page: https://510kreport.com/device/K073537
Methodology: https://510kreport.com/methodology