# K201405: LabPro Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 30, 2020 after 94 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020322 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070346: Dade Behring Labpro Alert Software System, Dade Behring, Inc. (2007) Summary page 4.

## Recalls of this device
- Jun 26, 2026 · Class II · Z-2888-2026: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Jun 26, 2026 · Class II · Z-2889-2026: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

## Indications for use
LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action. LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to the LabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices.

Source page: https://510kreport.com/device/K201405
Methodology: https://510kreport.com/methodology