MICROSTREP PLUS PANEL, VANCOMYCIN

K983953 · Dade Microscan, Inc. · JWY · Jan 14, 2000 · Microbiology

Device Facts

• Record ID: K983953
• Device Name: MICROSTREP PLUS PANEL, VANCOMYCIN
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended 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 non-entercoccal 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.

Device Story

MicroScan® MICroSTREP plus™ Panel is an in vitro diagnostic device for determining bacterial susceptibility to Vancomycin. The device consists of a test panel containing antimicrobial agents. Clinical laboratory personnel inoculate the panel with colonies grown on solid media; the panel is then incubated for 20-24 hours at 35°C in a non-CO2 incubator. The results are read visually by the clinician. The output provides quantitative or qualitative susceptibility data, which assists healthcare providers in selecting appropriate antibiotic therapy for patients with streptococcal infections. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. External evaluation conducted using fresh and stock clinical isolates and challenge strains. Performance compared to NCCLS frozen Reference Panel. Results showed 99% Essential Agreement for Vancomycin. Reproducibility and quality control testing demonstrated acceptable results.

Technological Characteristics

Microdilution MIC panel. Inoculated with bacterial colonies; incubated 20-24 hours at 35°C +/- 1°C in non-CO2 incubator. Visual reading of antimicrobial susceptibility. Vancomycin concentrations: 0.03 - 16 mcg/ml.

Indications for Use

Indicated for determining antimicrobial susceptibility of aerobic non-enterococcal streptococci, including Streptococcus pneumoniae, to Vancomycin.

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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## JAN 1 4 2000

### 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Sr. Associate, Regulatory Affairs |
| Fax: | 916-374-3144 |
| Date prepared: | December 13, 1999 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Vancomycin |
| Indication for Use: | For determining antimicrobic susceptibility of aerobic non-enterococcal<br>streptococci including Streptococcus pneumoniae |
| Predicate device: | MicroScan® Streptococcus MIC panel (K963641) |

#### 510(k) Summary:

animaly." morobour - mr. 2700 11:27 pm susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae

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 with surproooooan 10 and 11 Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

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

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™ The Shellar overline of Cormance with an NCCLS frozen Reference panel. The MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99% for Vancomycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility with Vancomycin.

Quality Control testing demonstrated acceptable results for Vancomycin.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JAN 1 4 2000

Ms. Cynthia Van Duker Sr. Associate Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard Wcst Sacramento, California 95691

Re: K983953

K765733 Regulatory Class: II Product Code: JWY Dated: December 13, 1999 Received: December 14, 1999

Dear Ms. Van Duker:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have leviewed your becally brothy not(x) not is substantially equivalent (for the indications for above and we have decemined the us as as as a vices marketed in interstate use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, commerce prior to May 20, 1770, the element with the provisions of the Federal or to devices that flave been reciassinou in acay, therefore, market the device, subject to the Food, Drug, alla Cosmette Act. The general controls provisions of the Act include general connous provisions of the Tet. The general 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 If your device is classified (bee aco viect to such additional controls. Existing major (Premations affecting your device can be found in the Code of Federal Regulations, Title 21, regulations anceling your device can ve read determination assumes compliance with the I arts 600 to 675. A substantially of e requirements, as set forth in the Quality System Current Good Manafacturing Pravises: General regulation (21 CFR Part 820) and that, Regulation (QS inspections, the Food and Drug Administration (FDA) will verify such through perfodic Q5 inspections, the F60 Pregulation may result in regulatory action. In assumptions. I andre to comply with the announcements concerning your device in the Federal addition, IDA may publish farmer announcement notification submission does not Register. Ticase note: this response to your sections 531 through 542 of the Act for devices arrect any obligation you hingin liarion Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Discase Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [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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Page of

510(k) Number (if known): K 98 3 953 Device Name: MICroSTREP plus " PANEC - VANCOMYCIN

Indications For Use:

The Indications for Use for the test panel are provided below and in the attachment which follows the FDA recommended format.

> The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercoccal 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 Vancomycin at concentrations of 0.03 - 16 mcg/ml to the test panel

The organisms which may be used for Vancomycin susceptibility testing in this panel are;

Aerobic non-enterococcal streptococci, including Streptococcus pneumoniae

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois
(Division Sign Off)

(Division Sigff)
Division of Clinical Laboratory Devices
510(k) Number K983953

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96