MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN

K062777 · Dade Behring, Inc. · LTT · Oct 10, 2006 · Microbiology

Device Facts

• Record ID: K062777
• Device Name: MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
• Applicant: Dade Behring, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

To determine bacterial antimicrobial agent susceptibility 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 visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

Device Story

MicroScan® MICroSTREP plus® Panel is a 96-well plastic dish containing dried microdilutions of antimicrobial agents. The device is used to determine the minimum inhibitory concentration (MIC) of Clindamycin for aerobic streptococci. The panel is rehydrated and inoculated with a standardized suspension of the organism in Mueller-Hinton broth supplemented with lysed horse blood. After 20-24 hours of incubation at 35°C, growth is assessed either manually or via the MicroScan® WalkAway instrument. The instrument uses optics light detection to measure growth in each well. The output provides quantitative and qualitative susceptibility results, which assist clinicians in selecting appropriate antibiotic therapy. The device is intended for use in clinical laboratory settings.

Clinical Evidence

Performance validated via external evaluations using CDC challenge strains and fresh/stock clinical isolates. Primary endpoint: Essential Agreement (EA) between instrument-read MIC results and expected results (CLSI frozen reference). Overall EA for Clindamycin was ≥95.7%, including S. pneumoniae. Reproducibility and precision testing performed on the WalkAway® instrument showed acceptable results.

Technological Characteristics

Miniaturized broth dilution panel; rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES. Sensing principle: visual or automated optical detection of bacterial growth inhibition. Connectivity: compatible with MicroScan® WalkAway instrument. Software: automated reading algorithm for MIC determination.

Indications for Use

Indicated for determining antimicrobial susceptibility of aerobic streptococci, including Streptococcus pneumoniae, to Clindamycin at concentrations of 0.015 – 2 µg/mL. For prescription use only; requires turbidity method of inoculum preparation.

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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(06277)

OCT 1 U 2006

## 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: | August 28, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Clindamycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic |
| | streptococci 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°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 ul 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 Clindamycin on the MicroScan® WalkAway instrument.

The external evaluations conducted with CDC Challenge strains 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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In addition, data on fresh and stock isolates is presented from the original external design validation of the manual method to support removing the "Do not report" limitation for S. pneumoniae with Clindamycin.

The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of ≥95.7% for Clindamycin compared with the Expected Result including S. pneumoniae.

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

Quality Control testing demonstrated acceptable results for Clindamycin.

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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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

Re: k062777

> Trade/Device Name: MicroScan MICroSTREP plus® Panel Clindamycin (0.015 to 2 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: August 28, 2006 Received: September 18, 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.

OCT 1 0 2006

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, attorn

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 .:

(To be assigned by FDA)

062777

MicroScan MICroSTREP plus® Panel Clindamycin (0.015 to 2 mcg/ml)

Intended Use

Indications for Use:

Device Name:

To determine bacterial antimicrobial agent susceptibility

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 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 Clindamycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel and the removal of the "Do not report" for S. pneumoniae.

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

Streptococci Streptococcus pneumoniae

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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510(k) K062777

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