MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN

K021181 · Dade Microscan, Inc. · JWY · Jun 17, 2002 · Microbiology

Device Facts

• Record ID: K021181
• Device Name: MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jun 17, 2002
• 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 an in vitro diagnostic device for determining antimicrobial susceptibility of aerobic streptococci. The device utilizes a miniaturized broth dilution method. Bacterial colonies are inoculated into panels containing various concentrations of antimicrobial agents (specifically Clarithromycin) diluted in Mueller-Hinton broth supplemented with 2-5% lysed horse blood and 50 mM HEPES. Panels are incubated for 20-24 hours at 35°C in a non-CO2 incubator. The minimum inhibitory concentration (MIC) is determined by visual observation of the lowest antimicrobial concentration inhibiting bacterial growth. The device is intended for use in clinical laboratory settings by trained personnel. Results assist healthcare providers in selecting appropriate antibiotic therapy for patients with streptococcal infections.

Clinical Evidence

Performance evaluated by comparing the subject panel to an NCCLS frozen Reference Panel using fresh and stock efficacy isolates and challenge strains. Results demonstrated an overall Essential Agreement of 98.6% for Clarithromycin. Reproducibility and precision testing were performed and found acceptable. Quality control testing met established criteria.

Technological Characteristics

Miniaturized broth dilution susceptibility test panel. Reagents: Mueller-Hinton broth, 2-5% lysed horse blood, 50 mM HEPES buffer. Antimicrobial agent: Clarithromycin (0.015 to 2 mcg/ml). Manual visual readout method. Incubation: 20-24 hours at 35°C +/- 1°C in non-CO2 environment.

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial agent susceptibility of aerobic streptococci, including Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Groups C, F, G streptococci, and viridans group streptococci, from colonies 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® Streptococcus MIC Panel (K963641)

Submission Summary (Full Text)

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KO2118/

JUN 1 7 2002

## 510(k) Summary Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | April 12, 2002 |
| 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, including<br>Streptococcus pneumoniae |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |

## 510(k) Summarv:

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.

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.

The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.

The Premarket Notification (510[k]) presents data in support of the new MICroSTREP plus™ Panel with Clarithromycin.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% for Clarithromycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Clarithromycin.

Quality Control testing demonstrated acceptable results for Clarithromycin.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with three heads. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 1 7 2002

Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

k021181 Re:

Trade/Device Name: MicroScan® MICroSTREP plus™ Panel For Clarithromycin Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: JWY Dated: April 12, 2002 Received: April 15, 2002

Dear Ms. Van Duker:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and : additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

| 510(k) No.: | K021181<br>(To be assigned by FDA) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan® MICroSTREP plus™ Panel |
| 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. |

This particular submission is for the addition of the antimicrobial Clarithromycin at concentrations of 0.015 to 2 mcg/ml to the test panel

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center">Freddie M. Poole</div> |
|---------------|-----------------------------------------------|
| | <div align="center">(Division Sign-Off)</div> |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K021181 |

| Prescription Use <span style="text-decoration: underline;">✓</span><br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use _ |
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(Optional Format 1-2-96)