(67 days)
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NCCLS frozen Levofloxacin Reference panel
No
The summary describes a traditional in-vitro diagnostic device (MIC panels) and its performance compared to a reference standard. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance evaluation focuses on essential agreement with a reference method, not on the performance of an AI/ML algorithm.
No
The device determines the susceptibility of antimicrobial agents, which is a diagnostic function, not a therapeutic one. Therapeutic devices are used to treat or cure diseases.
Yes
The device is described as determining "antimicrobial agent susceptibility," which is a diagnostic function to help guide treatment decisions.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels, specifically MicroScan™ Dried Gram-Negative MIC/Combo Panels," which are physical panels used for testing, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To determine antimicrobial agent susceptibility." This is a classic example of an in vitro diagnostic test, as it involves analyzing a sample (likely a bacterial culture) outside of the body to provide information about a patient's condition (in this case, how susceptible a specific bacteria is to different antibiotics).
- Device Description: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels." MIC panels are a standard method used in clinical microbiology laboratories to perform antimicrobial susceptibility testing, which is an in vitro diagnostic procedure.
- Performance Studies: The performance studies compare the device to a "NCCLS frozen Levofloxacin Reference panel," which is a reference standard used in in vitro diagnostic testing for antimicrobial susceptibility. The metrics reported (Essential Agreement) are also relevant to the performance evaluation of IVDs.
The information provided clearly indicates that this device is designed to perform a test on a biological sample in vitro (outside the body) to provide diagnostic information.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility
Product codes
Not Found
Device Description
Microdilution Minimum Inhibitory Concentration (MIC) Panels
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
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
The external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MicroScan® Dried Gram-Negative Levolloxacin Panel by comparing their performance with an NCCLS frozen Levofloxacin Reference panel.
Summary of Performance Studies
The MicroScan® Dried Gran-Negative LevoNoxacin Panel demonstrated acceptable efficacy performance with an overall Essential Agreement of 100% when compared with the frozen Levolloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the MicroScan® Dried Gram-Negative Levolloxacin Panel demonstrated accepable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-40 and WalkAway") was used.
Quality Control performance was acceptable for the MicroScan® Dried Gram-Negative Levolloxacin Panel.
Key Metrics
Essential Agreement of 100%
Predicate Device(s)
NCCLS Frozen Levofloxacin Reference Panels
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin Premarket Notification February 21, 1997
K970676 MAY - 2 1997
DADE
DADE NIERN
MicroScan Inc 1584 Enterprise Boulevard West Sacramento, CA 95691 916.372.1900
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Sharolyn Lentsch, Sr. Regulatory Affairs Administrator |
| Fax: | 916-374-3144 |
| Date prepared: | February 21, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan™ Dried Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Levofloxacin |
| Predicate device: | NCCLS Frozen Levofloxacin Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel with Levotloxacin demonstrated substanially equivalent performance when compared with an NCCLS frozen Levolloxacin Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
The Premarket Notification (510/k)) presents data in support of the new antimicrobial, Levofloxacin, for the MicroScan® Dried Gram-Negative MIC/Combo Panels
The external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MicroScan® Dried Gram-Negative Levolloxacin Panel by comparing their performance with an NCCLS frozen Levofloxacin Reference panel.
The MicroScan® Dried Gran-Negative LevoNoxacin Panel demonstrated acceptable efficacy performance with an overall Essential Agreement of 100% when compared with the frozen Levolloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the MicroScan® Dried Gram-Negative Levolloxacin Panel demonstrated accepable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-40 and WalkAway") was used.
Quality Control performance was acceptable for the MicroScan® Dried Gram-Negative Levolloxacin Panel.