(162 days)
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No
The description explicitly states the software is "rule-based" and does not mention any AI/ML terms or concepts.
No
The software system alerts users to unusual or out-of-range results and allows for changes in interpretations, but it does not directly treat, prevent, or mitigate a disease or condition in a patient.
No
The software notifies users of unusual conditions or out-of-range results and allows changes to interpretations, but it does not directly diagnose disease or provide a definitive clinical diagnosis.
Yes
The device description explicitly states it is a "rule-based software application within the LabPro Data Management System Software version 3.0" and does not mention any associated hardware components being part of the device itself. It interacts with existing instruments and software but is presented as a software-only addition.
Based on the provided information, the Dade Behring LabPro AlertEx Software System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with the LabPro Data Management System Software and MicroScan® Instruments. These instruments are used for in vitro diagnostic testing, specifically for organism identification and antibiotic susceptibility testing. The software's function is to process and interpret the results generated by these IVD instruments.
- Device Description: It's described as a rule-based software application within a data management system that handles results from MicroScan instruments. This further reinforces its role in processing and managing data from IVD tests.
- Functionality: The software notifies users of unusual conditions or out-of-range results from these tests and allows for changes to organism identifications and susceptibility interpretations. This directly relates to the interpretation and reporting of IVD test results.
- Predicate Device: The predicate device listed (K040099; BDXpert System resident on the EpiCenter System) is also a software system used in conjunction with laboratory instruments for processing and interpreting diagnostic test results, which are typically considered IVDs.
While the document doesn't explicitly state "in vitro diagnostic," the context of its use with MicroScan instruments for organism identification and susceptibility testing, and its function in processing and interpreting these results, strongly indicates that it is an IVD device. It's a software component that supports and enhances the functionality of other IVD instruments.
N/A
Intended Use / 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 SZ, 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.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The Dade Behring LabPro AlertEx Software System is a rule-based software application within the LabPro Data Management System Software version 3.0. The initial LabPro software releases (prior to version 3.0) contained Alert functionality that automatically notified the user of unusual conditions or out-of-range results that may warrant further analysis or action. The LabPro Alertex software offers added functionality including the ability to change the organism identification (ID) and/or antimicrobial susceptibility testing (AST) interpretations.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
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.(b)
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.”
0
JUL 18 2007
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Robert Eusebio, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | February 2, 2007 |
| Product Name: | Microbiology rule-based software system |
| Trade Name: | Dade Behring LabPro AlertEx Software System |
| Intended 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. | |
| 510(k) Notification: | New microbiology rule-based software system – Dade |
| Behring LabPro AlertEx Software System | |
| Predicate device: | BDXpert System resident on the EpiCenter System |
| (K040099) |
510(k) Summary:
The Dade Behring LabPro AlertEx Software System is a rule-based software application within the LabPro Data Management System Software version 3.0. The initial LabPro software releases (prior to version 3.0) contained Alert functionality that automatically notified the user of unusual conditions or out-of-range results that may warrant further analysis or action. The LabPro Alertex software offers added functionality including the ability to change the organism identification (ID) and/or antimicrobial susceptibility testing (AST) interpretations.
The proposed LabPro AlertEx Software System substantially equivalent to the BDXpert System resident on the EpiCenter System, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510[k]) presents the software development and verification and validation testing processes used for the LabPro Alertex Software.
The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract design of an eagle with three lines representing its wings and three curved lines below, possibly representing water or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 8 2007
Mr. Robert Eusebio Regulatory Affairs Specialist Dade Behring, Inc. 2040 Enterprise Blvd West Sacramento, CA 95691
Re: K070346
Trade/Device Name: Dade Behring LabPro AlertEx Software System Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short Term Incubation Cycle Antimicrobial Susceptibility Device Regulatory Class: Class II Product Code: LON
Dated: July 9, 2007 Received: July 10, 2007
Dear Mr. Eusebio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, autum
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ڀلام ڪيو
Device Name: Dade Behring LabPro AlertEx Software System
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 SZ, 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.
Prescription Use X (Part 21 CFR 801 Subpart D) · AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
fall atsm
Division Sign-Off
Division Sign-Off
Office of In Vitro Dlagno Device Evaluation and Safety
510(k) K070246
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Alert 510k final.doc