MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID

K020937 · Dade Microscan, Inc. · JWY · May 6, 2002 · Microbiology

Device Facts

• Record ID: K020937
• Device Name: MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: May 6, 2002
• 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. This particular submission is for the addition of the antimicrobial Amoxicillin/Clavulanic Acid at concentrations of 0.015/0.008 to 16/8 mcg/ml to the test panel. The organisms which may be used for Amoxicillin/ Clavulanic Acid susceptibility testing in this panel are: Streptococcus pneumoniae

Device Story

MicroScan® MICroSTREP plus™ Panel is an in vitro diagnostic device for determining antimicrobial susceptibility of aerobic streptococci. Device consists of miniaturized broth dilution panels containing various antimicrobial agents. Clinical laboratory personnel inoculate panels with standardized organism suspensions in saline, rehydrated with Mueller-Hinton broth supplemented with 2-5% lysed horse blood and buffered with 50 mM HEPES. Panels are incubated for 20-24 hours at 35°C in a non-CO2 incubator. Technicians manually read the minimum inhibitory concentration (MIC) by observing the lowest antimicrobial concentration inhibiting visible growth. Results assist clinicians in selecting appropriate antibiotic therapy for patients with streptococcal infections.

Clinical Evidence

Bench testing only. Performance evaluated by comparing the MICroSTREP plus™ Panel to an NCCLS frozen Reference Panel using fresh and stock clinical isolates and challenge strains. Results demonstrated an overall Essential Agreement of 99% for Amoxicillin/Clavulanic Acid. Reproducibility and precision testing showed acceptable results. Quality control testing confirmed performance standards were met.

Technological Characteristics

Miniaturized broth dilution susceptibility test. Panels contain antimicrobial agents diluted in water/buffer/broth. Rehydration medium: Mueller-Hinton broth, 2-5% lysed horse blood, 50 mM HEPES buffer. Manual visual reading of growth inhibition. Non-CO2 incubation at 35°C +/- 1°C for 20-24 hours.

Indications for Use

Indicated for determining antimicrobial susceptibility of aerobic streptococci, including Streptococcus pneumoniae, to Amoxicillin/Clavulanic Acid.

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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K020937

# MAY 0 6 2002

### 510(k) Summary Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|---------------------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | March 21, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Amoxicillin/Clavulanic Acid |
| Indication for Use | For determining antimicrobic susceptibility with Streptococcus pneumoniae |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |

#### 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 inculation, 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 (MC) 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 MCroSTREP plus™ Panel with Amoxicillin/Clavulanic Acid.

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 MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99% for Amoxicillin/Clavulanic Acid when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Amoxicillin/ Clavulanic Acid.

Quality Control testing demonstrated acceptable results for Amoxicillin/Clavulanic Acid.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k020937 Re:

K020937
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Amoxicillin/Clavulanic acid at 0.015/0.008-16/8 µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 21, 2002 Received: March 22, 2002

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encreative) it it's enactment date of the Medical Device Amendments, or to conimeres prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Treef the device, subject to the general controls provisions of the Act. The Tourmay, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classined (600 a00 ro) als. Existing major regulations affecting your device can inay be subject to such additions, 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 I lease be advisou that I Dr over device complies with other requirements of the Act that I Dri has made a acterimations administered by other Federal agencies. You must of any I cacal statuted and reguirements, including, but not limited to: registration and listing (21 Comply with an the 11et 31equirements, we see and manufacturing practice requirements as set CI IC rate 077, laoemig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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/dsma/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 .:

Device Name:

Intended Use

Indications for Use:

(To be assigned by FDA)

MicroScan® MICroSTREP plus™ Panel

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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.

This particular submission is for the addition of the antimicrobial Amoxicillin/Clavulanic Acid at concentrations of 0.015/0.008 to 16/8 mcg/ml to the test panel

The organisms which may be used for Amoxicillin/ Clavulanic Acid susceptibility testing in this panel are:

Streptococcus pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K020937 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div>✓</div> |
|----------------------|--------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)