# K151639: ABL80 FLEX and ABL80 FLEX CO-OX

- Pathway: 510(k) (Traditional)
- Applicant: Sendx Medical, Inc.
- Decided: Dec 7, 2015 after 172 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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.
No later device cites it as a predicate yet.
0 of 18 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 6.

## Indications for use
The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX analyzer system 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. For in vitro diagnostic use. The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX CO-OX analyzer system 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. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K151639
Methodology: https://510kreport.com/methodology