# K132691: ABL90 Flex

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Nov 13, 2014 after 442 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: 6 generations back to K861087 (1986). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050869: Modification to ABL800 Flex, Radiometer Medical Aps (2005) Summary page 5.

## Most influential descendants
- K160153: ABL90 Flex Plus (2016), 2 descendants of its own
- K252207: ABL90 FLEX PLUS System, safeCLINITUBES (2026), 0 descendants of its own
- K240998: ABL90 FLEX PLUS System (2024), 0 descendants of its own

## Indications for use
Intended Use: The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order. Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates.

Source page: https://510kreport.com/device/K132691
Methodology: https://510kreport.com/methodology