(90 days)
Not Found
No
The description details a traditional broth dilution susceptibility test method and does not mention any AI or ML components.
No.
This device is designed to determine antimicrobial agent susceptibility, which aids in diagnosing and guiding treatment, but it does not directly treat or alleviate a disease. It's an in-vitro diagnostic device.
Yes
The device is designed to determine the susceptibility of microorganisms to antimicrobial agents, which is a diagnostic function used to guide treatment decisions.
No
The device description clearly describes a physical panel with dehydrated antimicrobial agents that are rehydrated and incubated. This is a hardware component, not a software-only device.
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 (bacterial colonies) outside of the body to provide information about a patient's condition (the susceptibility of the bacteria to different drugs).
- Device Description: The description details a laboratory test that uses a panel with dried antimicrobial agents to determine the minimum inhibitory concentration (MIC) of these agents against a bacterial culture. This process is performed in vitro (in a lab setting, outside the body).
- Performance Studies: The performance studies compare the device's results to a reference panel, which is typical for validating an IVD. The metrics used (Essential Agreement and Categorical Agreement) are standard for evaluating the performance of antimicrobial susceptibility tests.
The entire description points to a device designed to perform a diagnostic test on a biological sample in a laboratory setting, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility
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
Not Found
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 evaluations were conducted with fresh, recent 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 a 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 levofloxacin.
The Dried Gram-Negative Panel inculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance with an Enterobacteriaceae except Salmonella spp. Essential Agreement (EA) of 95.9% and Categorical Agreement (CA) of 96.7%, Enterobacteriaceae for Salmonella spp. EA of 100.0% and CA of 98.8%, and Pseudomonas aeruginosa EA of 93.6% and CA of 91.4% for levofloxacin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with levofloxacin, 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 levofloxacin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) of 95.9% and Categorical Agreement (CA) of 96.7% for Enterobacteriaceae except Salmonella spp.
Essential Agreement (EA) of 100.0% and Categorical Agreement (CA) of 98.8% for Enterobacteriaceae for Salmonella spp.
Essential Agreement (EA) of 93.6% and Categorical Agreement (CA) of 91.4% 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.
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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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2020
Beckman Coulter, Inc. Elaine Duncan Senior Analyst Regulatory Affairs 1584 Enterprise Blvd West Sacramento, California 95630
Re: K193358
Trade/Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008 -16 µg/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: December 3, 2019 Received: December 4, 2019
Dear Elaine Duncan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol on the left, with two curved white lines inside. To the right of the symbol is the text "BECKMAN" in bold, followed by "COULTER" in a larger, bolder font. The logo is simple and professional, using a combination of a visual symbol and text to represent the company.
510(k) Summarv
510(k) Submission Information:
| Device Manufacturer: | Beckman Coulter |
|---|---|
| Contact name: | Elaine Duncan, Senior Analyst Regulatory Affairs |
| Phone: | 916-374-3279 |
| Fax: | 916-374-2480 |
| Date prepared: | December 2, 2019 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008 - |
| 16 µg/mL) | |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | Updated Breakpoints - Levofloxacin |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels Meropenem - (K192355) |
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-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 a 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 levofloxacin.
The external evaluations were conducted with fresh, recent 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 inculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance with an Enterobacteriaceae except Salmonella spp. Essential Agreement (EA) of 95.9% and Categorical Agreement (CA) of 96.7%, Enterobacteriaceae for Salmonella spp. EA of 100.0% and CA of 98.8%, and Pseudomonas aeruginosa EA of 93.6% and CA of 91.4% for levofloxacin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with levofloxacin, 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 levofloxacin.
Beckman Coulter, the stylized logo, and the Beckner Coulter product and service marks or registered trademarks of man Coulter. Inc. in the United States and other countries
Prompt is a registered trademark of 3M Company, St. Paul, MN USA