MICROSCAN MICROSTREP PLUS PANEL

K061872 · Dade Behring, Inc. · LRG · Aug 23, 2006 · Microbiology

Device Facts

• Record ID: K061872
• Device Name: MICROSCAN MICROSTREP PLUS PANEL
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Aug 23, 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. It uses panels containing various antimicrobial agents diluted in water, buffer, or broth. Clinical samples (bacterial colonies) are inoculated into panels rehydrated with Mueller-Hinton broth supplemented with lysed horse blood and HEPES. Panels are incubated for 20-24 hours at 35°C. The system determines the Minimum Inhibitory Concentration (MIC) of the antimicrobial agent. Results are obtained either by manual visual inspection or by using the MicroScan WalkAway instrument. The instrument automates the reading of growth inhibition. This device is used in clinical laboratory settings to guide antimicrobial therapy decisions by identifying the susceptibility profile of the patient's bacterial infection, potentially improving treatment outcomes.

Clinical Evidence

Bench testing only. Performance evaluated using stock and CDC Challenge strains. The study compared instrument-read results for Trimethoprim/Sulfamethoxazole against expected results determined by CLSI frozen Reference Panels. Results showed 100% Essential Agreement. Reproducibility and precision testing confirmed acceptable performance on the WalkAway instrument.

Technological Characteristics

Miniaturized broth dilution susceptibility test. Panels contain antimicrobial agents in water/buffer/broth. Rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES. Incubation at 35°C +/- 1°C for 20-24 hours. Readout via manual visual inspection or automated MicroScan WalkAway instrument. Connectivity via WalkAway instrument integration.

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial susceptibility of aerobic streptococci, including Streptococcus pneumoniae, grown on solid media.

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)

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

# AUG 2 3 2005

### 510(k) Summary Information:

| Device Manufacturer: | Dade Behring Inc. |
|----------------------|-------------------------------------------------------------------------------------|
| Contact name: | Maureen Mende, Regulatory Affairs Group Manager |
| Phone/Fax: | 916-374-3174/916-374-3144 |
| Date prepared: | June 26, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to<br>Trimethoprim/Sulfamethoxazole |
| Indication for Use: | For determining antimicrobic susceptibility with<br><i>Streptococcus pneumoniae</i> |
| 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°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. 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 Trimethoprim/Sulfamethoxazole 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

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

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 100% for Trimethoprim/Sulfamethoxazole instrument read results compared with the Expected Result.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Trimethoprim/ Sulfamethoxazole and the WalkAway® instrument.

Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.

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

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 eagle with three wing-like shapes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## AUG 2 3 2006

Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 2040 Enterprise Boulevard West Scaramento, California 95691

Re: k061872

> Trade/Device Name: MicroScan MICroSTREP plus® Panel Trimethoprim/Sulfamethoxazole (0.06/1.15 - 8/152 mcg/ml) Regulation Number: 21 CFR & 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: June 28, 2006 Received: July 19, 2006

Dear Ms. Mende:

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).

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

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, artton

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

{4}------------------------------------------------

#### Indication for Use Statement

| 510(k) No.: | K061872<br>(To be assigned by FDA) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan MICroSTREP plus ^® Panel<br>Trimethoprim/Sulfamethoxazole (0.06/1.15 - 8/152 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><i>Streptococcus pneumoniae</i> . After inoculation, panels are incubated<br>for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and<br>read visually according to the Package Insert. Additionally, the<br>panels may be incubated in and read by a MicroScan ^® WalkAway<br>instrument. |

This particular submission is for the addition of instrument read capability of the antimicrobial Trimethoprim/Sulfamethoxazole, at concentrations of 0.06/1.15 to 8/152 mcg/ml on the MicroScan MICroSTREP plus^® Panel.

The organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing on this panel are:

*Streptococcus pneumoniae*

| Prescription Use <img alt="Checkmark" src=""/><br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use ________ |
|------------------------------------------------------------------------|----|-------------------------------|
|------------------------------------------------------------------------|----|-------------------------------|

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

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

Sall
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) \$\frac{K_{0}6(87)}{}\$

viii