MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN

K062585 · Dade Behring, Inc. · LRG · Sep 19, 2006 · Microbiology

Device Facts

• Record ID: K062585
• Device Name: MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Sep 19, 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 azithromycin. Panels are rehydrated with Mueller-Hinton broth supplemented with 2–5% lysed horse blood and inoculated with aerobic streptococci (target 5 × 10⁵ CFU/mL). 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 device determines the Minimum Inhibitory Concentration (MIC) by identifying the lowest antimicrobial concentration that inhibits bacterial growth. This automated reading capability allows clinicians to obtain susceptibility results for azithromycin, aiding in the selection of appropriate antimicrobial therapy for patients with streptococcal infections.

Clinical Evidence

Bench testing only. Reproducibility was assessed using 10 isolates across 3 sites, demonstrating >95% reproducibility for both manual and automated methods. Comparison studies using 70 CDC challenge isolates showed 95.7% Essential Agreement (EA) for both manual and automated reading methods compared to the reference broth dilution method. No very major or major discrepancies were observed. Quality control was performed using S. pneumoniae ATCC 49619, with both reading methods producing identical modes.

Technological Characteristics

Miniaturized broth dilution panel; 96-well format; utilizes Mueller-Hinton broth with 2-5% lysed horse blood and 50 mM HEPES buffer. Automated optical reading via MicroScan WalkAway instrument. Incubation at 35°C +/- 1°C in non-CO2 environment.

Indications for Use

Indicated for testing Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococci (Groups C,F,G), and viridans group streptococci using the MicroScan® WalkAway System.

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 (K021169)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K062585". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters having exaggerated curves.

## 510(k) Summary Information:

## SEP 1 9 2006

| Device Manufacturer: | Dade Behring Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Contact name: | Shannon Popson, Regulatory Affairs Manager |
| Phone/Fax: | 916-374-3330/916-374-3144 |
| Date prepared: | August 18, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Azithromycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci including Streptococcus pneumoniae |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K021169) |

## 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 Azithromycin 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

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

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 Azithromycin instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Azithromycin.

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

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three tail feathers.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Shannon Popson Regulatory Affairs Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

SEP 1 9 2006

k062585 Re:

Trade/Device Name: MicroScan MICroSTREP plus® Panel Azithromycin (0.12-4 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: August 18, 2006 Received: September 1, 2006

Dear Ms. Popson:

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, atton

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

162585

To be assigned by FDA)

510(k) No .:

Device Name:

MicroScan MICroSTREP plus® Panel Azithromycin (0.12 - 4 mcg/ml)

Intended Use

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°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 Azithromycin, at concentrations of 0.12 to 4 mcg/m1 on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Azithromycin susceptibility testing in this panel are:

Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus agalactiae Streptococci (Groups C, F, G) viridans group streptococci

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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 Poole
Division Sign-Off

Page 1 of *1* **Office of In Vitro Diagnostic Device**
**Evaluation and Safety**
viii

176258

viii