# K070346: Dade Behring Labpro Alert Software System

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 18, 2007 after 162 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020322 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040099: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2004) Summary page 1.

## Most influential descendants
- K201405: LabPro Data Management System (2020), 0 descendants of its own

## Indications for use
The Dade Behring LabPro AlertEx Software System is intended for use with the LabPro Data Management System Software, version 3.0 and MicroScan' Instruments (e.g., WalkAway, S, autoSCAN-4). The AlertEx Software notifies the user of unusual conditions, or out-of-range results that may warrant further analysis or action, and/or provides the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations.

Source page: https://510kreport.com/device/K070346
Methodology: https://510kreport.com/methodology