MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN

K063299 · Dade Behring, Inc. · LRG · Nov 27, 2006 · Microbiology

Device Facts

• Record ID: K063299
• Device Name: MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Nov 27, 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 96-well plastic dish containing dehydrated microdilutions of antimicrobics. Panels are rehydrated with Mueller-Hinton broth supplemented with 2-5% lysed horse blood and inoculated with standardized organism suspension (approx. 5 × 10⁵ CFU/mL). After 20-24 hours incubation at 35°C, growth is assessed. The device adds automated reading capability via the MicroScan® WalkAway System, which uses optics light detection to measure growth in wells. The system determines the Minimum Inhibitory Concentration (MIC) by identifying the lowest concentration showing growth inhibition. Results are used by clinicians to determine antimicrobial susceptibility of aerobic streptococci, aiding in appropriate antibiotic selection for patients.

Clinical Evidence

Bench testing only. Reproducibility study (10 isolates, 3 sites, 3 days, triplicate) showed >95% reproducibility for both manual and automated methods. Comparison study of 70 challenge isolates (including 53 S. pneumoniae) demonstrated 98.6% Essential Agreement (EA) for the automated method compared to reference broth dilution, with no very major discrepancies and acceptable minor/major error rates. No clinical efficacy studies were required as performance was established via manual reading in the predicate submission.

Technological Characteristics

Miniaturized broth microdilution panel. Rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES. Incubation: 20-24 hours at 35°C +/- 1°C. Readout: Manual visual or automated via MicroScan® WalkAway instrument. Connectivity: Integrated with WalkAway system.

Indications for Use

Indicated for testing Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococci (Groups C,F, and G) and viridans group streptococci. 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

Submission Summary (Full Text)

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K063299

NOV 2 7 200E

## 510(k) Summary Information:

| Device Manufacturer: | Dade Behring Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Contact name: | May Morishima, Regulatory Affairs Administrator |
| Phone/Fax: | 916-374-2006/916-374-3144 |
| Date prepared: | October 11, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Clarithromycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci<br>including Streptococcus pneumoniae. |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |

## 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, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/-1 ℃ in a non-CO2 incubator, and read according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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) and buffered with 50 mM HEPES, after inoculation 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 substantially equivalent 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 Clarithromycin on the MicroScan® WalkAway instrument.

The external evaluation was conducted with stock and CDC Challenge strains. The external 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.

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The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agrecment of 98.6% for Clarithromycin instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Clarithromycin.

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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 and Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 27 2006

Ms. May Morishima Dade Behring Inc. Microscan 2040 Enterprise Blvd West Sacramento, CA 95691

Re: k063299

> Trade/Device Name: MicroScan MICroSTREP plus® Panel Clarithromycin (0.06 – 2 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG, LTT Dated: October 11, 2006 Received: November 1, 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 FFA may publish further announcements concerning your device in the Federal Degister.

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. Your 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 10gally marketed predicate device results in a classification for your device and thus, perror to 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 tollified non ber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Sally, artm

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.:

K063299 (To be assigned by FDA)

MicroScan MICroSTREP plus® Panel Clarithromycin (0.06 -- 2 mcg/ml)

Intended Use

Device Name:

To determine bacterial antimicrobial agent susceptibility

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, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

This particular submission is for the addition of instrument read capability of the antimicrobial Clarithromycin, at concentrations of 0.06 - 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Clarithromycin susceptibility testing on this panel are:

> Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Streptococci (Groups C, F, G) viridans group streptococci

Prescription Use X (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)

Freddi tu. Poole

Division Sign-Off

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