(135 days)
Not Found
No
The summary describes a standard broth dilution susceptibility test system and its performance compared to a reference method. There is no mention of AI or ML in the device description, intended use, or performance studies. While the device can be read with "MicroScan instrumentation," the description of the reading process (determining the lowest concentration showing inhibition of growth) does not suggest the use of AI/ML for interpretation.
No.
The device is used to determine the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function, not a therapeutic one. It helps guide treatment but does not directly treat a condition or disease.
Yes
The device is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of bacterial colonies, which provides information for diagnosing the effectiveness of various antimicrobial agents against specific pathogens. This information is crucial for guiding treatment decisions, thus serving a diagnostic purpose.
No
The device is a physical panel containing dried antimicrobial agents used for susceptibility testing, which is a hardware component. While it can be read with instrumentation, the core device itself is not software-only.
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 definition of an in vitro diagnostic test, as it's performed on a sample (bacterial colonies) outside of the body to provide information about a patient's condition (the susceptibility of the bacteria causing an infection to certain 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 antimicrobial susceptibility. The process involves rehydrating the panel with a standardized suspension of the organism and reading the results after incubation, all of which are in vitro procedures.
- Regulatory Context: The document mentions comparison with a "CLSI frozen Reference panel" and adherence to the "FDA document 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems: Guidance for Industry and FDA'". This indicates that the device falls under the regulatory framework for AST systems, which are a type of IVD.
- Predicate Device: The mention of a predicate device (K162740 MicroScan Dried Gram-Negative MIC/Combo Panels - Imipenem) which is also an AST system, further supports its classification as an IVD.
Therefore, based on the provided information, the MicroScan Dried Gram-Negative MIC/Combo Panel is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroScan Dried 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 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the antimicrobial ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel.
The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:
Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Morganii, Proteus mirabilis. Pseudomonas aeruginosa. Providencia rettgeri, Providencia stuartii, and Serratia marcescens
Product codes (comma separated list FDA assigned to the subject device)
LTT, JWY, LRG, LTW
Device Description
MicroScan Dried 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 antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in 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 a non-CO2 incubator for 16-20 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 Dried Gram-Negative Panel by comparing its performance with a CLSI frozen Reference panel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed MicroScan Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an CLSI 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 August 28, 2009. The Dried Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 95% for Enterobacteriaceae and 96.3% for Pseudomonas aeruginosa when using our most common inoculum and read method for ceftazidime/avibactam when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with ceftazidime/avibactam, regardless of which inoculum method (i.e., Turbidity or Prompt™), or instrument (autoSCAN-4 instrument or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for ceftazidime/avibactam.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 95% for Enterobacteriaceae and 96.3% for Pseudomonas aeruginosa.
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 Dried Gram-Negative MIC/Combo Panels - Imipenem (K162740)
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.
Not Found
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).
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).
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December 15, 2017
Beckman Coulter, Inc. Teresa Wong Senior Regulatory Analyst 1584 Enterprise Blvd. West Sacramento, California 95691
Re: K172337
Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Codes: LTT. JWY. LRG. LTW Dated: August 1, 2017 Received: August 2, 2017
Dear Teresa Wong:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172337
Device Name
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 µg/mL)
Indications for Use (Describe)
The MicroScan Dried 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 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the antimicrobial ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel.
The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:
Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Morganii, Proteus mirabilis. Pseudomonas aeruginosa. Providencia rettgeri, Providencia stuartii, and Serratia marcescens
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol on the left, followed by the company name "BECKMAN COULTER" in bold, black font. The symbol appears to be a stylized representation of two curved shapes within the circle.
510(k) Summarv
510(k) Submission Information:
| Device Manufacturer: | Beckman Coulter |
|---|---|
| Contact name: | Teresa Wong, Senior Analyst Regulatory Affairs |
| Phone: | 916-374-2432 |
| Fax: | 916-374-2119 |
| Date prepared: | October 27, 2017 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam |
| (0.25/4 – 64/4 µg/mL) | |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial agent - Ceftazidime/Avibactam |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels - Imipenem (K162740) |
510(k) Summary:
MicroScan Dried Gram-Neqative 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 antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in 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 a non-CO2 incubator for 16-20 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 Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an CLSI 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 August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Negative MIC/Combo Panel with ceftazidime/avibactam.
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 Dried Gram-Negative Panel by comparing its performance with a CLSI frozen Reference panel. The Dried Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 95% for Enterobacteriaceae and 96.3% for Pseudomonas aeruginosa when using our most common inoculum and read method for ceftazidime/avibactam when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with ceftazidime/avibactam, regardless of which inoculum method (i.e., Turbidity or Prompt™), or instrument (autoSCAN-4 instrument or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for ceftazidime/avibactam.
Beckman Coulter, the stylized logo, MicroScan, and WalkAway are trademarks of Beckman Coulter and the stylized logo are registered with the USPTO.
Prompt™ is a trademark of 3M Company, St. Paul, MN USA