MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)

K063099 · Dade Behring, Inc. · LRG · Nov 1, 2006 · Microbiology

Device Facts

• Record ID: K063099
• Device Name: MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

To determine bacterial antimicrobial agent susceptibility

Device Story

MicroScan MICroSTREP plus® Panel is a miniaturized broth dilution susceptibility test system. Input: bacterial colonies grown on solid media. Process: panels rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES; inoculated with standardized organism suspension; incubated 20-24 hours at 35°C. Output: Minimum Inhibitory Concentration (MIC) determined either visually or via MicroScan WalkAway instrument. Used in clinical laboratories by technicians. Instrument read provides automated growth inhibition detection, aiding clinicians in selecting appropriate antimicrobial therapy for streptococcal infections.

Clinical Evidence

Bench testing only. Reproducibility study (n=360) across 4 sites showed >95% reproducibility for both manual and automated methods. Method comparison using 70 challenge isolates (including 53 S. pneumoniae CDC strains) compared automated reading to reference broth dilution. Automated reading achieved 95.7% Essential Agreement (EA) and 96.7% Evaluable EA. No very major or major discrepancies were observed. QC performance met CLSI standards.

Technological Characteristics

Miniaturized broth dilution panel; contains antimicrobial agent Cefepime (0.015 - 8 mcg/ml). Rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES. Incubation: 20-24 hours at 35°C +/- 1°C. Readout: visual or automated via MicroScan WalkAway instrument. Connectivity: instrument-based data processing.

Indications for Use

Indicated for testing Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, and viridans group streptococci to determine antimicrobial susceptibility to Cefepime (0.015 – 8 µg/mL). Prescription use only. Turbidity method of inoculum preparation required.

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® Panel (K021188)

Submission Summary (Full Text)

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## 510(k) Summary Information:

| Device Manufacturer: Dade Behring Inc. | | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------|--|
| Contact name: | May Morishima, Regulatory Affairs Administrator | NOV - 1 2006 | |
| Phone/Fax: | 916-374-2006/916-374-3144 | | |
| Date prepared: | October 4, 2006 | | |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | | |
| Trade Name: | MicroScan MICroSTREP plus® Panel | | |
| Intended Use: | To determine bacterial susceptibility to Cefepime | | |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci<br>including Streptococcus pneumoniae | | |
| Predicate device: | MicroScan® MICroSTREP plus® Panel (K021188) | | |

### 510(k) Summary:

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, andiniteroofal agent subceptions, or versite = culation, panels are incubated for 20 = 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. I ho annimer only case of at a started in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellereontoont one origing the with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, rfinen orolation of the broth with a standardized suspension of the organism in saline. 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. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.

The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated I ho propoted mixalent performance with streptococcal isolates when compared with an expected result generated on a 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 February 5, 2003.

This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus® Panel with Cefepime on the MicroScan® WalkAway instrument.

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The evaluations were conducted with stock and CDC Challenge strains. The evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 95.7% for Cefepime instrument read results compared with the Expected Result.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefepime and the WalkAway® instrument.

Quality Control testing demonstrated acceptable results for Cefepime.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The logo is in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. May Morishima Regulatory Affairs Administrator Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

NOV - 1 2006

Re: k063099

Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefepime (0.015 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: October 4, 2006 Received: October 11, 2006

Dear Ms. Morishima:

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Sally, autum

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

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# Indication for Use Statement

| 510(k) No.: | K063099<br>(To be assigned by FDA) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan MICroSTREP plus® Panel<br>Cefepime (0.015 - 8 mcg/ml) |
| Intended Use | To determine bacterial antimicrobial agent susceptibility |
| Indications for Use: | The MicroScan MICroSTREP plus® Panel is used to determine<br>quantitative and/or qualitative antimicrobial agent susceptibility of<br>colonies grown on solid media of aerobic streptococci, including<br>Streptococcus pneumoniae. After inoculation, panels are incubated<br>for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read<br>visually according to the Package Insert. Additionally, the panels may<br>be incubated in and read by a MicroScan® WalkAway instrument.<br>This particular submission is for the addition of instrument read<br>capability of the antimicrobial Cefepime, at concentrations of<br>0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel.<br>The organisms which may be used for Cefepime susceptibility testing<br>on this panel are:<br>Streptococcus pneumoniae<br>Streptococcus pyogenes (Lancefield's Group A streptococci)<br>Streptococcus agalactiae (Lancefield's Group B streptococci)<br>Viridans group streptococci |
| Prescription Use | X<br>(Part 21 CFR 801 Subpart D) |
| | AND/OR |
| | Over-The-Counter Use<br>(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 Tu. Poole
Division Sign-Off

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K063099