(317 days)
Not Found
No
The device description and performance studies focus on a physical inoculation method and its equivalence to a standard turbidity method, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an accessory used to standardize inocula for antimicrobial susceptibility tests, not to treat or prevent disease.
No
The device is described as a system used to standardize inocula for antimicrobial susceptibility tests, acting as an accessory to MicroScan panels. Its function is to prepare samples for testing, not to perform diagnosis itself.
No
The device description explicitly states it consists of an inoculation wand and a bottle of diluent, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used to "standardize inocula for microdilution antimicrobial susceptibility tests." Antimicrobial susceptibility testing is a laboratory test performed on biological samples (bacteria) to determine their sensitivity to various antimicrobial agents. This falls squarely within the definition of an in vitro diagnostic test.
- Device Description: The device is designed to prepare a standardized bacterial inoculum, which is a crucial step in performing in vitro diagnostic tests for antimicrobial susceptibility.
- Accessory to IVD Panels: It is described as an "accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels." These panels are themselves IVD devices used for antimicrobial susceptibility testing. An accessory specifically designed for use with an IVD device is typically considered an IVD itself or an IVD accessory.
- Performance Studies: The performance studies described involve evaluating the device's performance in the context of antimicrobial susceptibility testing, comparing it to established methods (CLSI broth microdilution reference method) and analyzing results based on guidelines for AST (Antimicrobial Susceptibility Test) systems. This further reinforces its role in an in vitro diagnostic process.
- Predicate Device: The predicate device listed is the "3M Prompt Inoculation System," which is also an inoculation system used for similar purposes in antimicrobial susceptibility testing, indicating a history of such devices being regulated as IVDs.
Based on the intended use, device description, its role as an accessory to other IVD panels, and the context of the performance studies, the MicroScan Prompt® Inoculation System-D is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroScan Prompt Inoculation System-D is used to standardize inoculation antimicrobial susceptibility tests.
The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.
Product codes (comma separated list FDA assigned to the subject device)
LIE
Device Description
The MicroScan Prompt Inoculation System-D is a method for obtaining standardized bacterial inoculum while eliminating the need for incubation and turbidity adjustment with inocula prepared according to the CLSI procedure. It consists of an inoculation wand and a bottle of diluent. The wand is a polypropylene rod with a breakaway collar that serves as a wiping mechanism. The rod is attached to a stopper. At the tip of the wand is a groove designed to hold a specific amount of bacteria equivalent to a 0.5 McFarland standard. Thirty (30) ml of diluent (Pluronic is used as the surfactant) are provided in the plastic bottle. Each kit contains 60 plastic bottles, each containing 30 ml of stabilized aqueous Pluronic surfactants and 62 inoculation wands.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance data obtained with the Prompt Inoculation System-D were evaluated in previously conducted studies described in recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels for each antimicrobial agent.
Performance of the MicroScan MIC/Combo panels were evaluated using the Prompt inoculation method and the turbidity method against the CLSI broth microdilution reference method and results were analyzed based on the recommended guidelines in the AST Class II Special Controls Guidance Document issued on August 28, 2009. Any antimicrobial agent specific performance notes or limitations are included in the applicable MicroScan MIC/Combo Panel procedural manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 5, 2023
Beckman Coulter, Inc. Sharon Cullen Senior Staff Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691
Re: K221493
Trade/Device Name: MicroScan Prompt Inoculation System-D Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LIE Dated: May 19, 2022 Received: May 23, 2022
Dear Sharon Cullen:
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
1
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) 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 (OS) 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 -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221493
Device Name MicroScan Prompt Inoculation System-D
Indications for Use (Describe)
The MicroScan Prompt Inoculation System-D is used to standardize inoculation antimicrobial susceptibility tests.
The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 top of the word "COULTER" in bold black letters. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Beckman Coulter, Inc. |
|---|---|
| Address: | 1584 Enterprise Blvd, West Sacramento, California 95691. |
| Contact name: | Sharon Cullen, Senior Staff Regulatory Affairs |
| Phone: | 916- 844-2953 |
| Fax: | 916-374-2480 |
| Date prepared: | March 24, 2023 |
| Product Name: | Prompt Inoculation System - MIC |
| Trade Name: | MicroScan Prompt Inoculation System-D |
| Intended Use: | To standardize inocula for microdilution antimicrobial susceptibility tests |
| Classification: | Class II |
| Product Code: | LIE |
| 510(k) Notification: | K221493 |
| Predicate device: | 3M Prompt Inoculation System K820299 (product 6307) |
510(k) Summary:
INTENDED USE
The MicroScan Prompt® Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility tests.
The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.
Device Description:
The MicroScan Prompt Inoculation System-D is a method for obtaining standardized bacterial inoculum while eliminating the need for incubation and turbidity adjustment with inocula prepared according to the CLSI procedure. It consists of an inoculation wand and a bottle of diluent. The wand is a polypropylene rod with a breakaway collar that serves as a wiping mechanism. The rod is attached to a stopper. At the tip of the wand is a groove designed to hold a specific amount of bacteria equivalent to a 0.5 McFarland standard. Thirty (30) ml of diluent (Pluronic is used as the surfactant) are provided in the plastic bottle. Each kit contains 60 plastic bottles, each containing 30 ml of stabilized aqueous Pluronic surfactants and 62 inoculation wands.
Principle of Operations:
The MicroScan Prompt Inoculation System-D is an in vitro accessory which aids in the inoculum proparation for use with MicroSan Dried Gram positive and/or Gram negative MIC/Combo panels for quantitative and qualitative antimicrobial susceptibility testing.
The MicroScan Prompt Inoculation System-D wand is touched to several bacterial colonies on a primary isolation plate, wiped, then placed in the plastic bottle. The bacteria are suspended by shaking the bottle. The bacterial suspension, which is equivalent to a 0.5 McFarland, is stable for four hours after preparation.
Comparison with the Predicate(s):
The MicroScan Prompt Inoculation System-D is substantial equivalent to the predicate device. Refer to Substantial Equivalence Table below.
4
| Comparison with the Predicate | ||
|---|---|---|
| Device & Predicate | ||
| Device(s): | K221493 | |
| (Product No. B1026-10D) | K820299 | |
| (Product 6307) | ||
| Device Trade Name | MicroScan Prompt | |
| Inoculation System-D | Prompt Inoculation | |
| General Device Characteristic Similarities | ||
| Intended Use | Used to standardize | |
| inocula for microdilution | ||
| antimicrobial susceptibility | ||
| tests. | Same | |
| Technology | At the tip of the wand is a | |
| groove designed to hold a | ||
| specific amount of | ||
| bacteria equivalent to a | ||
| 0.5 McFarland standard. | Same | |
| Specimen | Isolated colonies from | |
| cultures. | Same | |
| Incubation Temperature | 35°C ±1°C | Same |
| Incubation Atmosphere | Aerobic | Same |
| Incubation Time | 16-20 hours (unless | |
| otherwise indicated with | ||
| an individual assay) | Same | |
| General Device Characteristic Differences | ||
| Hold Time (stability of bacteria | ||
| in solution) | 4 hours | 2 hours |
| Reading Method | Automated or Manual | Manual |
| Antimicrobial Susceptibility | ||
| Test | MicroSan MIC/Combo | |
| Panel | CLSI broth Microdilution | |
| Method | ||
| Diluents | Pluronic as the surfactant | |
| and removal of NaCL. | 0.02% aqueous Tween 80 | |
| Storage | 2-27°C |