(90 days)
To determine antimicrobial agent susceptibility
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.
This document describes the premarket notification (510(k)) for Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) for determining antimicrobial agent susceptibility.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Guidance Document: "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009) | Reported Device Performance (Levofloxacin) on the Dried Gram-Negative Panel with Prompt® and WalkAway Instrument |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable performance" compared to a CLSI frozen Reference Panel. | Enterobacteriaceae (except Salmonella spp.): 95.9% |
| Enterobacteriaceae (Salmonella spp.): 100.0% | ||
| Pseudomonas aeruginosa: 93.6% | ||
| Categorical Agreement (CA) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable performance" compared to a CLSI frozen Reference Panel. | Enterobacteriaceae (except Salmonella spp.): 96.7% |
| Enterobacteriaceae (Salmonella spp.): 98.8% | ||
| Pseudomonas aeruginosa: 91.4% | ||
| Reproducibility and Precision | "Acceptable reproducibility and precision" | Demonstrated acceptable reproducibility and precision with levofloxacin (Turbidity or Prompt® inoculum, autoSCAN-4 or WalkAway instrument) |
| Quality Control (QC) Testing | "Acceptable results" | Demonstrated acceptable results for levofloxacin |
Note: The FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA" typically specifies numerical acceptance criteria for Essential Agreement and Categorical Agreement (e.g., typically ≥ 90% for EA and CA), but these specific numerical thresholds are not explicitly detailed in this provided text. The text only states that the performance was "acceptable" as defined in that guidance document.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains." However, the exact sample size (number of isolates/strains) for the test set is not provided in the given text.
The data provenance is not explicitly stated in terms of country of origin. It is a retrospective study design since it used "stock Efficacy isolates and stock Challenge strains" and compared the device's performance to a CLSI frozen Reference Panel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For antimicrobial susceptibility testing, the "ground truth" is typically established by recognized reference methods, such as the broth microdilution method as outlined by CLSI (Clinical and Laboratory Standards Institute), which inherently does not involve human expert consensus in the same way imaging or clinical diagnosis studies might. The CLSI frozen Reference Panel served as the gold standard for comparison.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of antimicrobial susceptibility testing. The comparison is made against a CLSI frozen Reference Panel, which itself is a standardized method, not subject to individual interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This study is for an antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the study describes the standalone performance of the MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin. The performance metrics (EA, CA) are reported for the device ("Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument") compared to the CLSI frozen Reference Panel. There is no human interpretation or intervention in the measurement process described beyond the initial setup/inoculation and reading by the automated WalkAway instrument.
7. The Type of Ground Truth Used
The ground truth used was a CLSI frozen Reference Panel. This represents a standardized, reference method for determining antimicrobial susceptibility, widely accepted as the gold standard in microbiology.
8. The Sample Size for the Training Set
Not applicable/provided. The document describes a performance evaluation study comparing a new device to a reference standard; it does not mention a "training set" in the context of machine learning or AI models. This device is not an AI algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/provided as there is no training set mentioned for this type of device.
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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
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- 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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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
§ 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).