(73 days)
NCCLS Frozen Cefepime Reference Panels
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No
The summary describes a traditional microdilution method for determining antimicrobial susceptibility, which relies on established biological and chemical principles, not AI/ML algorithms. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is used to determine antimicrobial agent susceptibility, which is a diagnostic function to inform treatment, not to directly treat or prevent a disease.
Yes
The device determines the susceptibility of antimicrobial agents, which is a diagnostic function to guide treatment decisions.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels," which are physical laboratory panels used for testing. The performance studies also refer to "Dried Cefepime panels" and comparisons to "frozen Ceference panels," indicating a hardware component.
Yes, 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 (specifically, how susceptible a particular bacteria is to different antibiotics).
- Device Description: "Microdilution Minimum Inhibitory Concentration (MIC) Panels" are a common type of IVD used in microbiology laboratories for susceptibility testing.
- Performance Studies: The description of performance studies comparing the device to a "frozen Ceference panel" (likely a reference standard for susceptibility testing) further confirms its role as a diagnostic test. The metrics like "Essential Agreement" are also typical for evaluating the performance of IVD devices.
- Predicate Device: The mention of "NCCLS Frozen Cefepime Reference Panels" as a predicate device indicates that this device is being compared to an existing, likely approved, IVD device for the same purpose.
All of these factors strongly indicate that this device is intended for use in vitro to diagnose or provide information about a patient's health status, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility
Product codes
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Device Description
MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels
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 proposed MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panel with Cefepime demonstrated substantially equivalent performance with an NCCLS frozen Cefepime Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
Both the gram-negative and gram-positive 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 Dried Cefepime panels by comparing their performance with an NCCLS frozen Ceference panel.
The Dried gram-negative Cefepime panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% when compared with the frozen Ceference panel. The Dried gram-positive Cefepime panel demonstrated acceptable performance with an overall Essential Agreement of 95.9% when compared with the frozen Cefepime Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the gram-negative and the gram-positive Dried Cefepine panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity, Log, Stationary, and Prompt), or instrument (autoScan-4 and WalkAway") was used.
Quality Control performance was acceptable for both the gram-negative and the gram-positive Dried Cefepine panels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 98.6% (gram-negative), Essential Agreement of 95.9% (gram-positive)
Predicate Device(s)
NCCLS Frozen Cefepime Reference Panels
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Attachment A - 510(k) SUMMARY
DADE INTERNATIONAL
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: | May 31, 1996 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan• Dried Gram-Negative and Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Cefepime |
| Predicate device: | NCCLS Frozen Cefepime Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panel with Cefepime demonstrated substantially equivalent performance with an NCCLS frozen Cefepime 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, Cefepime, for the MicroScan® Dried Gram-negative and Gram-positive MIC/Combo Panels.
Both the gram-negative and gram-positive 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 Dried Cefepime panels by comparing their performance with an NCCLS frozen Ceference panel.
The Dried gram-negative Cefepime panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% when compared with the frozen Ceference panel. The Dried gram-positive Cefepime panel demonstrated acceptable performance with an overall Essential Agreement of 95.9% when compared with the frozen Cefepime Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the gram-negative and the gram-positive Dried Cefepine panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity, Log, Stationary, and Prompt), or instrument (autoScan-4 and WalkAway") was used.
Quality Control performance was acceptable for both the gram-negative and the gram-positive Dried Cefepine panels.