# K050869: Modification to ABL800 Flex

- Pathway: 510(k) (Special)
- Applicant: Radiometer Medical Aps
- Decided: Aug 11, 2005 after 127 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861087 (1986). 16 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041874: ABL800 Flex, Radiometer Medical Aps (2004) Summary page 1.

## Most influential descendants
- K092686: ABL90 Flex Series (2010), 12 descendants of its own
- K120197: ABL90 Flex (2012), 6 descendants of its own
- K122729: ABL90 Flex (2012), 5 descendants of its own
- K132691: ABL90 Flex (2014), 3 descendants of its own
- K131988: ABL90 Flex Analyzer (2013), 3 descendants of its own

## Recalls of this device
- Jul 6, 2006 · Not classified · Z-0115-2007: Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is op

## Indications for use
Indications: The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, P02.pCO 2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters p02 and pCO 2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids.

Source page: https://510kreport.com/device/K050869
Methodology: https://510kreport.com/methodology