← Product Code [LON](/productcode/LON) · K070346

# DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM (K070346)

_Dade Behring, Inc. · LON · Jul 18, 2007 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K070346

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [LON](/productcode/LON.md)
- **Decision Date:** Jul 18, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Software as a Medical Device

## Indications for Use

To notify the user of unusual conditions, or out-of-range results that may warrant further analysis or action and/or to provide the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations.

## Device Story

LabPro AlertEX is a rule-based software application integrated into the LabPro Data Management System. It processes microbial identification (ID) and antimicrobial susceptibility test (AST) results from MicroScan instruments or manual entry. The system compares these results against a pre-configured table of rules based on standard microbiology references to identify unusual patterns. Users can activate pre-configured rules or create custom rules based on patient ID, institution, specimen source, or biochemical reactions. The software provides alert messages and allows users to modify organism ID or AST interpretations. It is used in clinical microbiology laboratories to assist technicians and clinicians in reviewing and refining test results, facilitating clinical decision-making regarding patient treatment.

## Clinical Evidence

No clinical data. Bench testing only; software verification and validation were performed to confirm the rule-based logic and system functionality.

## Technological Characteristics

Rule-based software application; operates as a module within LabPro Data Management System v3.0; interfaces with MicroScan instrumentation; provides automated alert logic and manual data editing capabilities.

## Regulatory Identification

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

## Predicate Devices

- BDXpert System resident on the EpiCenter System (k040099)

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE AND INSTRUMENT TEMPLATE

A. 510(k) Number:
k070346

B. Analyte:
Software for the LabPro AlertEX Data Management System Software, version 3.0 and MicroScan® instruments (e.g., WalkAway SI, autoSCAN-4)

C. Type of Test:
Software for AST reading and interpretation

D. Applicant:
Dade Behring Inc.

E. Proprietary and Established Names:
Dade Behring LabPro AlertEX Software System

F. Regulatory Information:
1. Regulation section:
21 CFR 866. 1645
2. Classification:
Class II
3. Product Code:
LON
4. Panel:
83 Microbiology

G. Intended Use:
1. Intended use:
The Dade Behring LabPro AlertEX Software System is intended for use with the LabPro AlertEX Data Management System Software, version 3.0 and MicroScan® instruments (e.g., WalkAway SI, autoSCAN-4)
2. Indication(s) for Use:
The AlertEX Software system is indicated to notify the user of unusual conditions, or out-of-range results that may warrant further analysis or action,

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and/or provide the user with the ability to change organism identification and/or antibiotic susceptibility test interpretations.

3. Special condition for use statement(s): Prescription Use
4. Special instrument Requirements: Not applicable

# H. Device Description:

The Dade Behring LabPro Data Management System is a Windows based software program used to manage data from MicroScan Instruments or manually entered microbiology test results.

# I. Substantial Equivalence Information:

1. Predicate device name(s): BDXpert System resident on the EpiCenter System
2. Predicate K number(s): k040099
3. Comparison with predicate:

|  DEVICE | PREDICATE  |
| --- | --- |
|  A. Similarities  |   |
|  |   |
|  Dade Behring LabPro AlertEX Software System does not perform test analysis | BD Xpert System resident on the Epicenter does not perform test analysis  |
|  Utilize additional information, such as specimen source, to provide the user with a more refined AST interpretation | Utilize additional information, such as specimen source, to provide the user with a more refined AST interpretation  |
|  Provide similar added functionality and the ability to change AST interpretations | Provide similar added functionality and the ability to change AST interpretations  |
|  SIR and MIC reported | SIR and MIC reported  |
|  |   |

# J. Standard/Guidance Document Referenced (if applicable):

Not Applicable

# K. Test Principle:

The Dade Behring LabPro Alert $_{\text{EX}}$  Software is a rule-based software application within the LabPro Data Management System Software. The Alert $_{\text{EX}}$  Software analyzes MicroScan microbial identification (ID) and antimicrobial agent susceptibility tests (AST) or other parameters (e.g. patient ID, institution, source) against a series of rules.

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When panels are read on a MicroScan Instrument, entered manually, or when editing stored patient results, the software compares processed test results against rules and conditions.

The LabPro AlertEX Software is provided to the MicroScan customers in a pre-configured condition with rules pre-defined based upon standard microbiology references. These rules are defined in a table which list susceptibility and ID patterns known to be unusual. Through customization the user may inactivate the pre-configured rules, but the user cannot edit the pre-configured rules. Additionally, user-defined rules may be added to the system to provide alert messages for results (e.g. previous isolation of a resistant organism from a particular patient, address specific physicians, locations, specimen sources or biochemical reactions.)

The LabPro AlertEX will add the capability to change organism ID, and/or generate AST interpretations based on defined parameters utilizing standard microbiology references. The preconfigured alert rules with ID and AST actions are inactive upon installation and must be activated by the user through customization.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
Not applicable
d. Detection limit (functional sensitivity:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:

3

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Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Not applicable

M. Instrument Name:

Microscan instruments

N. System Descriptions:

1. Modes of Operation:

Not applicable

2. Software:

The firm provided their level of concern and the supporting rationale of moderate. As recommended in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the following was reviewed and found acceptable: Level of Concern, Software Description, Device Hazard Analysis, Software Requirement Specification (SRS), Architectural Design Chart, Software Design Specification, Traceability, Analysis, Development Life cycle, Verification and Validation Testing, Revision Level History, Unresolved Anomalies (Defects), and Release Version Number.

FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types: Yes ☑ or No ☐

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3. Sample Identification:
Not applicable

4. Specimen Sampling and Handling:
Not applicable

5. Assay Types:
Not applicable

6. Reaction Types:
Not applicable

7. Calibration:
Not applicable

8. Quality Control:
Not applicable

O. Other Supportive Instrument Performance Characteristics Data Not Covered In The "L. Performance Characteristics" Section Of The SE Determination Decision Summary.
Not applicable

P. Conclusion:
The information contained within this submission is sufficient to meet the software concerns as described in the Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, and it is recommended that, from a software standpoint, this device be considered substantially equivalent.

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**Source:** [https://fda-staging.innolitics.com/device/K070346](https://fda-staging.innolitics.com/device/K070346)

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