# K051968: ABL8X7 Flex

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Oct 16, 2006 after 453 days
- Product code: CGL (Electrode, Ion Based, Enzymatic, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 4 (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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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.
- K043218: ABL800 Flex with Flexq Module, Model ABL8XX, Radiometer Medical Aps (2005) Summary page 1.
- K002290: Abl-700 Series, Model Abl 7XX (Various Models), Radiometer Medical A/S (2000) Summary page 1.
- K973292: I-Stat System, I-Stat Corp. (1997) Summary page 1.

## Recalls of this device
- Jul 2, 2018 · Class II · Z-0801-2019: From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be 
- Oct 29, 2014 · Class II · Z-1293-2015: Negative drift on QC during in-use lifetime of CREA membranes can be observed.
- Dec 16, 2011 · Not classified · Z-1008-2012: When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bot
- Mar 26, 2009 · Not classified · Z-1015-2010: Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analyt

## Indications for use
The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter Creatinine. Creatinine measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Source page: https://510kreport.com/device/K051968
Methodology: https://510kreport.com/methodology