(57 days)
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No
The summary describes a traditional broth dilution susceptibility test read by an automated instrument, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
This device is an in vitro diagnostic (IVD) tool designed to determine the susceptibility of bacteria to antimicrobial agents, which assists in guiding treatment decisions, but does not directly treat or diagnose a disease.
Yes
The device determines the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function used to guide treatment decisions for infections.
No
The device description explicitly states it involves physical panels ("micro-titer wells in dried form") and requires incubation and reading on a hardware system (WalkAway® SI System or equivalent). This indicates it is a hardware-based device with potential software components for reading and interpretation, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "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." This is a diagnostic test performed in vitro (outside the body) on a biological sample (bacterial colonies).
- Device Description: The description details how the test works by using miniaturized broth dilution susceptibility tests in micro-titer wells, inoculated with a standardized suspension of the organism, and incubated. This process is a standard method for in vitro diagnostic testing of microbial susceptibility.
- Performance Studies: The performance studies compare the device's performance to a "NCCLS frozen Reference panel," which is a common practice for validating in vitro diagnostic devices. The metrics reported (Essential Agreement and Categorical Agreement) are also typical for evaluating the performance of antimicrobial susceptibility testing devices.
The core function of the device is to provide information about the susceptibility of bacteria to antimicrobial agents, which is a crucial piece of information for diagnosing and guiding treatment of infections. This clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility.
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 (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobials Ofloxacin, Norfloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin on the Synergies plus" Gram-Negative MIC/Combo Panels.
Product codes
LON
Device Description
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels 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 MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. The rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by 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 rapID/S 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
The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.
The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 98.3% for Offloxacin, 97.4% for Nortloxacin, 98.2% for Levofloxacin, 98.6% for Lomefloxacin, 98.6% for Sparfloxacin and 98.3% for Ciprofloxacin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Offloxacin, Norfloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Ofloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin.
Key Metrics
Essential Agreement (%):
Ciprofloxacin: 640/651 (98.3%)
Levofloxacin: 639/651 (98.2%)
Lomefloxacin: 642/651 (98.6%)
Norfloxacin: 634/651 (97.4%)
Ofloxacin: 640/651 (98.3%)
Sparfloxacin: 561/569 (98.6%)
Categorical Agreement (%):
Ciprofloxacin: 604/651 (92.8%)
Levofloxacin: 614/651 (94.3%)
Lomefloxacin: 618/651 (94.9%)
Norfloxacin: 609/651 (93.5%)
Ofloxacin: 609/651 (93.5%)
Sparfloxacin: 548/569 (96.3%)
Predicate Device(s)
MicroScan Dried Gram Negative MIC/Combo Panels
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Clearance is requested for an MIC range which allows MicroScan the ability to select any number of antimicrobic for inclusion on future panels. The combination of dily halls chosen will be verified for acceptable performance, as defined in the DRAFT FDA guidance document titled "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000, prior to release.
§ 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.”
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510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Group Manager Regulatory Affairs |
| Fax: | 916-374-3144 |
| Date prepared: | January 15, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® rapID/S plus™ Gram-Negative MIC/Combo panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | Antimicrobials: Ofloxacin, Norfloxacin, Levofloxacin, Lomefloxacin Sparfloxacin, and Ciprofloxacin |
| Predicate device: | MicroScan Dried Gram Negative MIC/Combo Panels |
510(k) Summary:
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels 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 MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. The rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Ofloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin.
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 rapID/S 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 rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 98.3% for Offloxacin, 97.4% for Nortloxacin, 98.2% for Levofloxacin, 98.6% for Lomefloxacin, 98.6% for Sparfloxacin and 98.3% for Ciprofloxacin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Offloxacin, Norfloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Ofloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin.
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Section 1. LABELING SUMMARY
Labeling Changes Requiring FDA Clearance Prior to Implementation
- Clearance is requested for an MIC range which allows MicroScan the ability to select . any number of antimicrobic for inclusion on future panels. The combination of dily halls chosen will be verified for acceptable performance, as defined in the DRAFT FDA guidance document titled "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000, prior to release. The dilutions requested, for use with gram-negative are indicated below:
| Antimicrobial | Panel Type | Abbreviation | MIC Dilutions
Requested |
|---------------|---------------|--------------|----------------------------|
| Ciprofloxacin | gram-negative | Cp | 0.25 – 8 µg/ml |
| Levofloxacin | gram-negative | Lvx | 0.5 - 16 µg/ml |
| Lomefloxacin | gram-negative | Lmf | 1.0 - 16 µg/ml |
| Norfloxacin | gram-negative | Nxn | 0.12 - 32 µg/ml |
| Ofloxacin | gram-negative | Ofx | 0.12 - 16 µg/ml |
| Sparfloxacin | gram-negative | Sfx | 0.5 - 8 µg/ml |
- The following FDA Interpretive Breakpoints will be added to the MicroScan® rapID/S plus™ Procedural Manuals:
| Interpretive Breakpoints1 | Antimicrobial Agents | Susceptible | Intermediate | Resistant |
|---|---|---|---|---|
| Ciprofloxacin | ≤1 | 2 | ≥4 | |
| Levofloxacin2 | ≤2 | 4 | ≥8 | |
| Lomefloxacin3 | ≤2 | 4 | ≥8 | |
| Norfloxacin3 | ≤4 | 8 | ≥16 | |
| Ofloxacin3 | ≤2 | 4 | ≥8 | |
| Sparfloxacin4 | ≤1 | 2 | ≥4 |
- Based on Interpretive Breakpoints as indicated in NCCLS Document M100-S11. There are antimicrobials included on the rapID/S plus™ panels that are not proven to be effective for treating clinical infections for all organisms that may be tested. For interpreting and reporting of antimicrobial results which have shown to be active against organism groups, tooth in chiro and in clinical infections, refer to NCCLS M100 Performance Standard Table1 or the pharmaceutical antibiotic labeling.
antiblotic laboling.
2. Interpretive criteria for urinary tract infections are only for P.aeruginosa and Other Non-Enterobacteriaceae,
-
Interpretive criteria applies to urinary tract infections only.
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Interpretive criteria applies to Enterobacteriaceae only.
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- The following Performance Characteristics claims will be added to the Procedural . Manual:
| Antimicrobial Agent | Essential Agreement (%) | Categorical Agreement (%) |
|---|---|---|
| Ciprofloxacin | 640/651(98.3) | 604/651 (92.8) |
| Levofloxacin | 639/651 (98.2) | 614/651 (94.3) |
| Lomefloxacin | 642/651 (98.6) | 618/651 (94.9) |
| Norfloxacin | 634/651 (97.4) | 609/651 (93.5) |
| Ofloxacin | 640/651 (98.3) | 609/651 (93.5) |
| Sparfloxacin | 561/569 (98.6) | 548/569 (96.3) |
Percent Agreement to Reference Method
- The following QC ranges will be added to the Quality Control Manual: .
| Antimicrobial
Agent | Abbreviation | E. coli
ATCC 25922
Range1 | P. aeruginosa
ATCC 27853
Range1 |
|------------------------|--------------|----------------------------------------|----------------------------------------------|
| Ciprofloxacin | Cp |