MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

K101425 · Siemens Healthcare Diagnostics · LRG · Sep 10, 2010 · Microbiology

Device Facts

• Record ID: K101425
• Device Name: MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
• Applicant: Siemens Healthcare Diagnostics
• Product Code: LRG · Microbiology
• Decision Date: Sep 10, 2010
• 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. This particular submission is for the addition of the antimicrobial Doripenem at concentrations of 0.008 to 32 mcg/ml to the test panel. The gram-negative organisms which may be used for Doripenem susceptibility testing in this panel are: Acinetobacter baumanii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Device Story

MicroScan® Dried Gram-Negative MIC/Combo Panels contain dehydrated Mueller Hinton Broth and nutrients with micro-dilutions of antimicrobial agents. Panels are rehydrated and inoculated with bacterial suspensions prepared via turbidity or Prompt® methods. After 16-20 hours of incubation at 35°C in non-CO2, growth is assessed to determine the Minimum Inhibitory Concentration (MIC). Testing is performed in clinical laboratories. Results are obtained via visual observation or automated reading using MicroScan® WalkAway® or autoSCAN®-4 systems. Automated systems use optical detection to measure growth inhibition. MIC results and categorical interpretations (SIR) assist clinicians in selecting appropriate antimicrobial therapy for gram-negative infections.

Clinical Evidence

Clinical efficacy testing conducted at three sites using 573 gram-negative isolates (535 intended for testing). Combined efficacy and challenge study results showed 97.0% Essential Agreement (EA) and 97.2% Category Agreement (CA). Reproducibility was >95% across all sites, days, and reading methods (manual, WalkAway, autoSCAN-4). No clinical sensitivity/specificity data required for AST systems; performance is based on comparison to reference broth dilution methods.

Technological Characteristics

Dried micro-dilution panels containing Mueller Hinton Broth and nutrients. Growth-based detection principle. Inoculation via turbidity or Prompt® methods. Incubation 16-20 hours at 35°C. Automated reading via optical detection (WalkAway® or autoSCAN-4 systems). Complies with CLSI M07-A8 and M100-S19 standards.

Indications for Use

Indicated for determining antimicrobial susceptibility of rapidly growing aerobic and facultative anaerobic gram-negative bacilli (Acinetobacter baumannii, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa) to Doripenem. 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- Ertapenem (k032706)

Submission Summary (Full Text)

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# X10/425 SEP 1 0 2010

### 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Siemens Healthcare Diagnostics |
|----------------------|-------------------------------------------------------------------------|
| Contact name: | Elisabeth Warriner, Regulatory Technical Specialist |
| Fax: | 916-374-3144 |
| Date prepared: | August 31, 2010 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Doripenem |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels -<br>Ertapenem (K032706) |

#### 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 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 Doripenem.

The external evaluation was 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. Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 97.0% for Doripenem when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Doripenem, regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN® -4 and WalkAway®) was used.

Quality Control testing demonstrated acceptable results for Doripenem.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Siemens Healthcare Diagnostics Inc. c/o Ms. Eliabeth Warriner Regulatory Technical Specialist 1584 Enterprise Blvd. West Sacramento, CA 95691

SEP 1 0 2010

Re: K101425

Trade/Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Doripenem (0.008-32ug/mL)

Regulation Number: 21 CFR 866.1640 ·

Regulation Name: Antimicrobial Susceptibility Test Powder

Regulatory Class: Class II

Product Code: LRG, JWY, LTT Dated: September 9, 2010

Received: September 10, 2010

Dear Ms. Warriner:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish farther 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

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Page 2 - Ms. Eliabeth Warriner

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Valgastin

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

SEP 1 0 2010

K101425

## 510(k) Number (if known): K. 10/425

Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Doripenem (0.008 -32 mcg/ml)

Indications For 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.

This particular submission is for the addition of the antimicrobial Doripenem at concentrations of 0.008 to 32 mcg/ml to the test panel.

The gram-negative organisms which may be used for Doripenem susceptibility testing in this panel are:

> Acinetobacter baumanii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie Rie. Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101425

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