(266 days)
No
The document describes a standard antimicrobial susceptibility test panel and its performance against a reference method. There is no mention of AI/ML in the device description, intended use, or performance studies. The reading can be done visually or by a MicroScan WalkAway instrument, neither of which are described as using AI/ML.
No
This device is an in vitro diagnostic (IVD) tool used to determine the susceptibility of bacteria to antimicrobial agents, aiding in treatment decisions but not directly providing therapy.
Yes
The device is used to determine the antimicrobial agent susceptibility of bacterial colonies, specifically Streptococcus pneumoniae, which is a diagnostic function as it provides information about the organism's characteristics relevant to treatment.
No
The device is a physical panel used for antimicrobial susceptibility testing, which is a hardware component. While it can be read manually or by a MicroScan WalkAway instrument (which also involves hardware), the core device itself is not software-only. The submission is for an update to the interpretative criteria (software/data), but the device being modified is a physical panel.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococcus pneumoniae." This is a diagnostic test performed in vitro (outside the body) on a biological sample (bacterial colonies).
- Device Description: The description details how the device works by performing "miniaturizations of the broth dilution susceptibility test" and determining the "minimum inhibitory concentration (MIC)" of antimicrobial agents. This is a standard method for in vitro diagnostic testing of bacterial susceptibility.
- Performance Studies: The performance studies describe evaluating the device's performance against a "CLSI frozen Reference panel," which is a common practice for validating IVD devices. The metrics reported (Essential Agreement and Categorical Agreement) are also typical for evaluating the performance of antimicrobial susceptibility testing devices.
The entire context of the document describes a device used to perform a diagnostic test on a biological sample to provide information about a patient's potential response to antimicrobial treatment, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococcus pneumoniae. After inoculation. panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
This particular Special 510(k) submission is for the addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 - 16 µg/mL on the MicroSCREP plus Panel (modification to K020939 and K062923).
Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert and/or as listed on the FDA Susceptibility Test Interpretative Criteria web site.
Streptococcus spp. Streptococcus pneumoniae
Product codes (comma separated list FDA assigned to the subject device)
JWY, LTT, LRG, JTZ, LTW
Device Description
MicroScan MICroSTREP plus Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35° + 1° in a non-CO2 incubator, and read according to the Procedural Manual.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115uL Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non- CO2 incubator for 20 – 24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
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 Challenge isolates. The external evaluations were designed to confirm the acceptability of the updated STIC for use with the Dried MICroSTREP plus 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 updated Streptococus pneumoniae FDA-recognized STIC for use with the MicroScan MICroSTREP plus Panels with tetracycline 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. This Special Premarket Notification (510[k]) presents combined efficacy and challenge data in support of the application of updated Streptococcus pneumoniae STIC for use with MicroScan MICroSTREP plus Panels with tetracycline.
The Dried MICroSTREP plus Panel inoculated with the turbidity inoculation method and manually read demonstrated acceptable performance with Streptoccus pneumoniae Essential Agreement (EA) of 90.2% and Categorical Agreement (CA) of 99.7% for tetracycline when compared with the frozen Reference panel.
Reproducibility testing located in K020939 and K062923 demonstrated acceptable reproducibility and precision with tetracycline, regardless of which read method (i.e., manual or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for tetracycline.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) of 90.2% and Categorical Agreement (CA) of 99.7% for tetracycline 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.
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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May 18, 2021
Beckman Coulter, Inc. Elaine Duncan Senior Analyst Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691
Re: K202423
Trade/Device Name: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LTT, LRG, JTZ, LTW Dated: August 12, 2020 Received: August 25, 2020
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
2
Indications for Use
510(k) Number (if known) K202423
Device Name
MicroScan MICroSTREP plus Panels with Tetracycline (0.06 - 16 ug/mL)
Indications for Use (Describe)
The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococcus pneumoniae. After inoculation. panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
This particular Special 510(k) submission is for the addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 - 16 µg/mL on the MicroSCREP plus Panel (modification to K020939 and K062923).
Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert and/or as listed on the FDA Susceptibility Test Interpretative Criteria web site.
Streptococcus spp. Streptococcus pneumoniae
| 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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Special 510(k) Summary
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: | August 12, 2020 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus Panels with Tetracycline (Te) (0.06 - 16 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Codes: | LTT, LRG, JWY, JTZ |
| Special 510(k) Notification: | Updated FDA-recognized STIC for Streptococcus pneumoniae with Tetracycline |
| Predicate device: | MicroScan MICroSTREP plus Tetracycline - (K020939 and K062923) |
510(k) Summary:
MicroScan MICroSTREP plus Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35° + 1° in a non-CO2 incubator, and read according to the Procedural Manual.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115uL Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non- CO2 incubator for 20 – 24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
The proposed updated Streptococus pneumoniae FDA-recognized STIC for use with the MicroScan MICroSTREP plus Panels with tetracycline 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. This Special Premarket Notification (510[k]) presents combined efficacy and challenge data in support of the application of updated Streptococcus pneumoniae STIC for use with MicroScan MICroSTREP plus Panels with tetracycline.
The external evaluations were conducted with fresh and Challenge isolates. The external evaluations were designed to confirm the acceptability of the updated STIC for use with the Dried MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. The Dried MICroSTREP plus Panel inoculated with the turbidity inoculation method and manually read demonstrated acceptable performance with Streptoccus pneumoniae Essential Agreement (EA) of 90.2% and Categorical Agreement (CA) of 99.7% for tetracycline when compared with the frozen Reference panel.
Reproducibility testing located in K020939 and K062923 demonstrated acceptable reproducibility and precision with tetracycline, regardless of which read method (i.e., manual or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for tetracycline.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries,