MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN

K081013 · Siemens Healthcare Diagnostics · LRG · Sep 8, 2008 · Microbiology

Device Facts

• Record ID: K081013
• Device Name: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
• Applicant: Siemens Healthcare Diagnostics
• Product Code: LRG · Microbiology
• Decision Date: Sep 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams. This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel. The gram-positive organisms which may be used for Cefoxitin Screen susceptibility testing in this panel are: Staphylococcus aureus Staphylococcus lugdunensis

Device Story

MicroScan® Dried Gram-Positive MIC/Combo Panels utilize dehydrated Mueller Hinton Broth and nutrients in microdilution wells. Inoculum prepared via turbidity or Prompt® method; panels rehydrated and incubated at 35°C for 16-20 hours. Device detects qualitative antimicrobial susceptibility; Cefoxitin Screen (CfxS) well (4 µg/mL) used alongside oxacillin MIC to assess resistance. Read manually or automatically via autoScan® 4 or WalkAway® instruments. Output provides MIC and categorical interpretation (SIR). Used in clinical microbiology laboratories to guide antibiotic selection for S. aureus and S. lugdunensis infections.

Clinical Evidence

Clinical evaluation compared Cefoxitin Screen performance against CLSI cefoxitin disk diffusion and mecA PCR using fresh/stock clinical isolates and challenge strains. Results: 97.8% categorical agreement vs. disk diffusion; 98.7% vs. mecA PCR. Sensitivity/Specificity vs. disk diffusion: 98.6%/96.9%. Sensitivity/Specificity vs. mecA PCR: 99.7%/97.7%. Reproducibility testing confirmed performance across different inoculum methods (Turbidity, Prompt) and instruments (autoSCAN-4, WalkAway).

Technological Characteristics

Miniaturized broth microdilution panels; dehydrated antimicrobial agents in wells. Rehydrated with water. Incubation 16-24 hours at 35°C. Compatible with visual reading or automated instrumentation (autoSCAN-4, WalkAway).

Indications for Use

Indicated for the addition of Cefoxitin Screen at 4 µg/mL to gram positive susceptibility panels for testing Staphylococcus aureus and Staphylococcus lugdunensis 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-Positive and Gram-Negative MIC/Combo Panels (K862140)

Submission Summary (Full Text)

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## 510(k) Summary

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## 510(k) Submission Information:

| Device Manufacturer: | Siemens Healthcare Diagnostics |
|----------------------|-------------------------------------------------------------------------------------------|
| Contact name: | Libby Warriner, Regulatory Affairs Senior Compliance Specialist |
| Fax: | 916-374-3144 |
| Date prepared: | April 7, 2008 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine the susceptibility of staphylococci to penicillinase-<br>stable beta-lactams |
| 510(k) Notification: | New antimicrobial test - Cefoxitin Screen |
| Predicate device: | MicroScan Dried Gram-Positive MIC/Combo Panels |

## 510(k) Summary:

MicroScan Dried Gram-Positive 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-positive cocci.

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 rchydrated 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-Positive MIC/Combo Panel with the Cefoxitin Screen demonstrated substantially equivalent performance when compared with the CLSI cefoxitin disk diffusion test and mecA PCR, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susccptibility Test (AST) Systems: Guidance for Industry and FDA", dated March 5, 2007, and "Guidance for Industry and FDA Staff-Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests", dated March 13, 2007. The Premarket Notification (510[k]) presents data in support of the MicroScan Dricd Gram-Positive MIC/Combo Pancl with the Cefoxitin Screen.

The external design validation (Clinical Trial) was conducted with fresh and stock Efficacv isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Pancl by comparing its performance with results of the CLSI cefoxitin disk diffusion test and mecA PCR. Challenge strains were compared to Expected Results determined prior to the evaluation.

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The Cefoxitin Screen dcmonstrated acceptable performance with an overall Categorical Agrecment of 97.8% when compared with the CLSI cefoxitin disk diffusion test, and 98.7% when compared to mecA PCR. Overall sensitivity was 98.6% and specificity was 96.9% compared to cefoxitin disk diffusion results. Overall sensitivity was 99.7% and specificity was 97.7% compared to mecA PCR results.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with the Cefoxitin Screen, 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 the Cefoxitin Screen Well (CfxS), cefoxitin at a concentration of 4 mcg/ml.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

SEP - 8 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Libby Warriner Regulatory Affairs Compliance Specialist Siemens Healthcare Diagnostics 2040 Enterprise Blyd West Sacramento, CA 95691

Re: k081013

Trade/Device Name: MicroScan® Dried Gram -- Positive MIC/Combo Panels with Cefoxitin Screen (4 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LRG Dated: August 25, 2008 Received: August 28, 2008

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 either class II (Special Controls) or class III (PMA), 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sally attayna

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

Enclosure

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## Indications for Use

510(k) Number (if known): KO8 |0 |3

Dovice Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with the Cefoxitin Screen (4 mcg/ml)

Indications For Use:

The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams.

This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel.

The gram-positive organisms which may be used for Cefoxitin Screen susceptibility testing in this panel are:

> Staphylococcus aureus Staphylococcus lugdunensis

Prescription Use V (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 Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K081013