MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)

K062375 · Dade Behring, Inc. · LRG · Oct 26, 2006 · Microbiology

Device Facts

• Record ID: K062375
• Device Name: MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Oct 26, 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. This particular submission is for the addition of instrument read capability of the antimicrobial Erythromycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Erythromycin susceptibility testing on this panel are: Streptococcus pneumoniae, Streptococcus pyogenes, viridans group streptococci.

Device Story

MicroScan® MICroSTREP plus® Panel is a 96-well plastic dish containing dehydrated antimicrobial agents. Panels are rehydrated with Mueller-Hinton broth supplemented with 2-5% lysed horse blood and inoculated with standardized bacterial suspensions (approx. 5 x 10⁵ CFU/mL). After 20-24 hours incubation at 35°C, growth is assessed to determine Minimum Inhibitory Concentration (MIC). The device adds automated reading capability via the MicroScan® WalkAway instrument using optics light detection, supplementing the existing manual reading method. The system provides quantitative and qualitative susceptibility results. Healthcare providers use these results to guide antimicrobial therapy for streptococcal infections. The automated reading method replaces manual visual inspection, reducing subjectivity and improving workflow efficiency in clinical microbiology laboratories.

Clinical Evidence

Bench testing only. Reproducibility study (10 isolates, 3 sites, 3 days, triplicate) showed >95% reproducibility for both manual and automated methods. Challenge study (n=70, including 53 S. pneumoniae CDC strains) compared automated reading to reference broth dilution and manual reading. Results showed 98.6% Essential Agreement (EA) for both methods. No major or very major discrepancies were observed; one minor error occurred in both methods. No clinical efficacy testing was required as the manual method was previously established.

Technological Characteristics

Miniaturized broth dilution susceptibility test system. Panels contain antimicrobial agents diluted in water, buffer, or broth. Rehydrated with Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and 50 mM HEPES. Incubation at 35°C +/- 1°C. Automated reading via MicroScan® WalkAway instrument. Connectivity: Integrated with WalkAway instrument system.

Indications for Use

Indicated for determining antimicrobial susceptibility of aerobic streptococci, including Streptococcus pneumoniae, Streptococcus pyogenes, and viridans group streptococci, using Erythromycin (0.015 to 2 mcg/ml).

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}------------------------------------------------

KO62375

OCT 26 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 2, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Erythromycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic<br>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 15 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 Erythromycin 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. The MICroSTREP plus® Panel demonstrated acceptable performance with

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

an overall Essential Agreement of 98.6% for Erythromycin instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Erythromycin.

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

Image /page/2/Picture/0 description: The image contains a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle emblem, which is a common symbol associated with the U.S. government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

OCT 26 2006

Re: k062375

> Trade/Device Name: MicroScan MICroSTREP plus® Panel Erythromycin (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 2, 2006 Received: September 25, 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, anton

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

062375
(To be assigned by FDA)

(To be assigned by FDA

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

Intended Use

Device Name:

510(k) No .:

Indications for 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.

This particular submission is for the addition of instrument read capability of the antimicrobial Erythromycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

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

> Streptococcus pneumoniae Streptococcus pyogenes viridans group streptococci

Prescription Use X (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)

AND/OR

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

Page 1 of 1 - 1

Division Sign-Off

Office of In Vites Diagnostic Device Evaluation and Safety

\$\varphi(k)\$ K\$^{06}\$2375

viii