MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)

K162740 · Beckman Coulter, Inc. · LTT · Mar 21, 2017 · Microbiology

Device Facts

• Record ID: K162740
• Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
• Applicant: Beckman Coulter, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Mar 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended 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.

Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels are miniaturized, dehydrated broth microdilution susceptibility tests. Device takes colonies grown on solid media as input; inoculates panels using turbidity or Prompt Inoculation System; incubates 16–20 hours at 35°C. Output is Minimum Inhibitory Concentration (MIC) and categorical interpretation (SIR). Used in clinical microbiology labs; read visually or via MicroScan WalkAway or autoSCAN-4 instruments. Results assist clinicians in selecting appropriate antimicrobial therapy for gram-negative infections. Limitations exist for specific species (P. aeruginosa, Acinetobacter, Proteus, Providencia, Serratia) regarding major errors or discrepant MICs compared to reference methods; retesting via turbidity method recommended for critical cases.

Clinical Evidence

Performance evaluated using 419 clinical and 179 challenge isolates. Study compared MicroScan panels (Prompt and turbidity inoculation; manual, WalkAway, and autoSCAN-4 read methods) against CLSI frozen broth microdilution reference. Enterobacteriaceae EA/CA >89.9%. Acinetobacter and P. aeruginosa showed acceptable EA, though Prompt inoculation showed increased major errors for these species, leading to labeling limitations. MIC trending analysis showed Enterobacteriaceae and P. aeruginosa MICs trended one dilution higher than reference. Reproducibility >98% across all methods.

Technological Characteristics

Miniaturized, dehydrated broth microdilution panels. Media: Mueller Hinton broth supplemented with calcium and magnesium. Inoculation: Turbidity or Prompt Inoculation System. Incubation: 35°C ± 1°C, 16–20 hours. Read methods: Manual, MicroScan WalkAway, or autoSCAN-4. Connectivity: Instrument-based automated reading. Sterilization: Not specified.

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial susceptibility of colonies of rapidly growing and facultative anaerobic gram-negative bacilli (Acinetobacter spp., Citrobacter spp., Enterobacter spp., E. coli, Klebsiella spp., Morganella morganii, Proteus vulgaris, Providencia rettgeri, and Pseudomonas aeruginosa) to imipenem (0.25–8 µg/mL). For prescription use only.

Regulatory Classification

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.

Predicate Devices

• MicroScan Dried Gram-Negative MIC/Combo Panels – Tigecycline (K083262)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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) | <div style="display:inline-block;">☒</div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;">☐</div> |

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## 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