(80 days)
MicroScan® Synergies plus™ Gram Negative MIC/Combo Panels
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No
The summary describes a traditional broth dilution susceptibility test system and its performance compared to a reference method. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the context of medical devices. The focus is on the chemical and biological aspects of the test and its agreement with a standard reference.
No
This device is an in-vitro diagnostic (IVD) tool used to determine the susceptibility of rapidly growing aerobic and facultative anaerobic gram-negative bacilli to antimicrobial agents. It is not designed for direct treatment or diagnosis of a patient's condition, but rather to provide information that can aid healthcare professionals in making treatment decisions.
Yes
The device is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of bacterial colonies, which falls under the definition of diagnosing the susceptibility of an organism to specific treatments. This information is critical for guiding the treatment of infections, making it a diagnostic device.
No
The device is a physical panel containing dehydrated antimicrobial agents and is intended for use with specific hardware (WalkAway SI or equivalent) for incubation and reading. While software may be involved in reading or interpreting the results from the panel, the core device itself is a physical, consumable product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the device is used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli." This is a classic example of an in vitro diagnostic test, as it analyzes biological samples (bacterial colonies) outside of the body to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description further clarifies that the tests are "miniaturizations of the broth dilution susceptibility test," which is a standard laboratory method for determining antibiotic susceptibility.
- Performance Studies: The performance studies compare the device's performance to a "NCCLS frozen Reference panel," which is a common practice for validating IVD devices.
- Predicate Device: The mention of a "Predicate Device" (MicroScan® Synergies plus™ Gram Negative MIC/Combo Panels) is also typical for IVD submissions, indicating a comparison to a previously cleared device.
All of these points strongly indicate that the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility.
The MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway SI or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefazolin, at concentrations of 0.5 to 32 ug/ml, to the test panel.
The gram-negative organisms which may be used for Cefazolin susceptibility testing in this panel are:
Escherichia coli
Klebsiella spp.
Proteus mirabilis
The MicroScan® Synergies plus" Gram-Negative Panels with Cefazolin is not intended for use with:
- Klebsiella oxytoca
Enterobacter spp.
Citrobacter freundii
Morganella morganii
Proteus vulgaris
Proteus penneri
Providencia spp
Serratia spp
Yersinia enterolitica
Product codes (comma separated list FDA assigned to the subject device)
LRG, LON
Device Description
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® S7 System or equivalent for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
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
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Synergies plus Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, 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)kl) presents data in support of the MicroScan® Synergies plus Gram-Negative MIC/Combo Panel with Cefazolin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Synergies plus Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Cefazolin when compared with the frozen NCCLS Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Turbidity inoculum preparation method and the WalkAway® SY System or equivalent. An additional reproducibility study was performed to obtain additional rapid (97% for Cefazolin
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.
MicroScan® Synergies plus™ Gram Negative MIC/Combo Panels
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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§ 866.1640 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
JUL 2 2 2004
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: | May 19, 2003 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Cefazolin |
| Predicate device: | MicroScan® Synergies plus™ Gram Negative MIC/Combo Panels |
510(k) Summary:
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® S7 System or equivalent for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, 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)kl) presents data in support of the MicroScan® Synergies plus Gram-Negative MIC/Combo Panel with Cefazolin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Synergies plus Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Cefazolin when compared with the frozen NCCLS Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Turbidity inoculum preparation method and the WalkAway® SY System or equivalent. An additional reproducibility study was performed to obtain additional rapid (