(172 days)
Not Found
No
The description focuses on traditional broth dilution susceptibility testing methods and does not mention any AI or ML components.
No
The device determines antimicrobial susceptibility of colonies and is used in a lab setting, not for direct treatment or diagnosis of a patient.
Yes
This device determines the antimicrobial susceptibility of bacteria, which is a diagnostic process used to identify effective treatments for infections.
No
The device is a physical panel containing dried antimicrobial agents used for laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to determine the susceptibility of microorganisms to antimicrobial agents. This is a diagnostic test performed in vitro (outside the body) on a sample (bacterial colonies).
- Device Description: It describes a miniaturized broth dilution susceptibility test, which is a common method for in vitro diagnostic testing of antimicrobial susceptibility.
- Performance Studies: The performance studies compare the device's results to a reference panel, which is typical for validating an IVD.
- Predicate Device: The mention of a predicate device (K083262) which is also an "Antimicrobial Susceptibility Test (AST) System" further confirms its classification as an IVD. AST systems are a well-established category of IVDs.
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 addition of the reformulated antimicrobial imipenem at concentrations of 0.25 to 8 ug/ml to the test panel.
The gram-negative organisms which may be used for imipenem susceptibility testing in this panel are:
Acinetobacter spp. Citrobacter spp. Escherichia coli, Klebsiella spp. Morganella morganii, Proteus vulgaris, Providencia rettgeri, and Pseudomonas aeruginosa
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-neqative 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
Not Found
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 Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Negative MIC/Combo Panel with imipenem.
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 95.5% for imipenem when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with imipenem, 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 imipenem.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 95.5% for imipenem when compared with the frozen Reference panel.
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 - Tigecycline (K083262)
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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2017
BECKMAN COULTER, INC. SHANNON POPSON STAFF REGULATORY AFFAIRS 1584 ENTERPRISE BLVD WEST SACRAMENTO CA 95691
Re: K162740
Trade/Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels With Imipenem (0.25 - 8 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LTT, JWY, LRG, LTW Dated: March 13, 2017 Received: March 15, 2017
Dear Ms. Popson:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -A
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) K162740
Device Name
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 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 addition of the reformulated antimicrobial imipenem at concentrations of 0.25 to 8 ug/ml to the test panel.
The gram-negative organisms which may be used for imipenem susceptibility testing in this panel are:
Acinetobacter spp. Citrobacter spp. Escherichia coli, Klebsiella spp. Morganella morganii, Proteus vulgaris, Providencia rettgeri, and Pseudomonas aeruginosa
| 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 circle with two white curved lines inside, followed by the words "BECKMAN" in bold black letters on the top line and "COULTER" in bold black letters on the bottom line. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Beckman Coulter |
|---|---|
| Contact name: | Shannon Popson, Staff Regulatory Affairs |
| Phone: | 916-374-3330 |
| Fax: | 916-374-2119 |
| Date prepared: | September 25, 2016 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 – 8 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | Reformulated antimicrobial - Imipenem |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels - Tigecycline (K083262) |
510(k) Summary:
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-neqative 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 imipenem.
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 95.5% for imipenem when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with imipenem, 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 imipenem.
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