MICROSCAN MICROSTEP

K111394 · Siemens Healthcare Diagnostics, Inc. · LTT · Jun 22, 2011 · Microbiology

Device Facts

• Record ID: K111394
• Device Name: MICROSCAN MICROSTEP
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Jun 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended 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 streptococci. After inoculation, panels are incubated for 20 - 24 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 Daptomycin at concentrations of 0.25 to 8 µg/ml to the test panel. The organisms which may be used for Daptomycin susceptibility testing in this panel are: Streptococcus pyogenes Streptoccocus agalactiae Streptococcus dysglactiae subsp.equisimilis

Device Story

MicroScan MICroSTREP plus panels are miniaturized broth dilution susceptibility tests; dehydrated antimicrobial agents in wells. Clinical lab personnel inoculate panels with standardized organism suspensions in Mueller-Hinton broth supplemented with 2-5% lysed horse blood. Panels incubated 20-24 hours at 35°C in non-CO2 incubator. Minimum Inhibitory Concentration (MIC) determined by manual visual inspection or automated reading via MicroScan WalkAway System. Output provides quantitative/qualitative susceptibility data; assists clinicians in selecting appropriate antibiotic therapy for streptococcal infections.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock efficacy isolates and challenge strains. Compared against CLSI frozen reference panel. Overall Essential Agreement for Daptomycin was 97%. Reproducibility and precision demonstrated for both manual and automated (WalkAway) read methods. Quality control testing met acceptance criteria.

Technological Characteristics

Miniaturized broth dilution panel; dehydrated antimicrobial agents in wells. Rehydrated with Mueller-Hinton broth + 2-5% lysed horse blood. Manual or automated (WalkAway system) optical reading. Non-CO2 incubation at 35°C. Standalone or integrated with MicroScan instrumentation.

Indications for Use

Indicated for determining antimicrobial susceptibility of aerobic streptococci (Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis) to Daptomycin (0.25–8 µg/mL). For prescription use.

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 MICroSTREP plus Panels - Levofloxacin (K020556)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 2 2 2011

### 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Siemens Healthcare Diagnostics |
|----------------------|-------------------------------------------------------------|
| Contact name: | Shannon Popson, Regulatory Technical Specialist |
| Fax: | 916-374-3330 |
| Date prepared: | May 12, 2011 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus® Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Daptomycin |
| Predicate device: | MicroScan MICroSTREP plus Panels - Levofloxacin (K020556) |

#### 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.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. 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. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAwav System.

The proposed MicroScan MICroSTREP plus 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 MICroSTREP plus Panel with Daptomycin.

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 MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97% for Daptomycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Daptomycin, regardless of which read method (manual and WalkAway® instrument) was used with the turbidity inoculation method.

Quality Control testing demonstrated acceptable results for Daptomycin.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics c/o Ms. Shannon Popson Regulatory Technical Specialist 1584 Enterprise Blvd. West Sacramento, CA 95691

JUN 2 2 2 2011

Re: K111394

Trade/Device Name: MicroScan® MICroSTREP plus® Panels Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: LTT, LTW, JWY, LRG Dated: May 16. 2011 Received: May 25, 2011

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.

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

{2}------------------------------------------------

Page 2 - Ms. Shannon Popson

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,

Vau, artyston

Sally A. Hojvat, 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

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: MicroScan® MICroSTREP plus® with Daptomycin (0.25 - 8 µg/ml)

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 streptococci. After inoculation, panels are incubated for 20 - 24 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 Daptomycin at concentrations of 0.25 to 8 µg/ml to the test panel.

The organisms which may be used for Daptomycin susceptibility testing in this panel are:

Streptococcus pyogenes Streptoccocus agalactiae Streptococcus dysglactiae subsp.equisimilis

AND/OR

Prescription Use V (Part 21 CFR 801 Subpart D) 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)

Concurrence of
Luddie Poole

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

510(k) K11394

Page 1 of 1