MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN

K972688 · Dade Microscan, Inc. · JWY · Sep 8, 1997 · Microbiology

Device Facts

• Record ID: K972688
• Device Name: MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

To determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin.

Device Story

MicroScan Dried Gram-Positive MIC/Combo Panels are in vitro diagnostic devices used in clinical laboratories to determine the minimum inhibitory concentration (MIC) of the antimicrobial agent Levofloxacin against specific gram-positive bacteria. The panels contain dried antimicrobial agents; bacterial isolates are inoculated into the panel wells. Following incubation, growth is assessed to determine susceptibility. The system is compatible with autoScan-4 and WalkAway instruments for automated reading and interpretation. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections, potentially improving clinical outcomes by ensuring targeted treatment.

Clinical Evidence

Performance was evaluated using fresh and stock efficacy isolates and stock challenge strains. The study compared the dried Levofloxacin panel against an NCCLS frozen reference panel. Results demonstrated an overall essential agreement of 99.4%. Reproducibility and precision were confirmed across different inoculum methods (Turbidity and Prompt) and instrument platforms (autoScan-4 and WalkAway). Quality control performance was acceptable.

Technological Characteristics

Microdilution panels containing dried antimicrobial agents. Compatible with automated reading via autoScan-4 and WalkAway systems. Supports multiple inoculum methods (Turbidity and Prompt).

Indications for Use

Indicated for determining susceptibility of gram-positive bacteria, specifically Enterococcus faecalis, Staphylococcus aureus, and Streptococcus pyogenes, to the antimicrobial agent Levofloxacin.

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

• NCCLS Frozen Levofloxacin Reference Panels

Submission Summary (Full Text)

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K972688

Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Levofloxacin Premarket Notification K972688 - Amendment 1 August 29, 1997

SEP - 8 1997

510(k) Summary

### DADE INTERNATIONAL

MicroScan Inc 1584 Enterprise Boulevard West Sacramento. CA 95691 916.372.1900

## 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|-------------------------------------------------------------|
| Contact name: | Sharolyn Lentsch, Sr. Regulatory Affairs Administrator |
| Fax: | 916-374-3144 |
| Date prepared: | July 3, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Levofloxacin |
| Predicate device: | NCCLS Frozen Levofloxacin Reference Panels |

### 510(k) Summary:

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Levofloxacin Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510/k)) presents data in support of a new antimicrobial Levofloxacin, for the MicroScan® Dried Gram-Positive MIC/Combo Panels.

The gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Levofloxacin panel by comparing its performance with an NCCLS frozen Levofloxacin Reference panel.

The Dried Gram-Positive Levofloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.4% when compared with the frozen Levofloxacin Reference panel.

Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Levofloxacin panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway Systems) was used.

Quality Control performance was acceptable for both the Gram-Positive Dried Levofloxacin panels.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 8 1997

Ms. Sharolyn Lentsch Senior Requlatory Affairs Administrator Dade International MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691

Re: K972688 MicroScan® Dried Gram Positive MIC/Combo Panels New Trade Name: Antimicrobial - Levofloxacin Regulatory Class: II Product Code: JWY II LRG Dated: July 3, 1997 Received: July 7, 1997

Dear Ms. Lentsch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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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 Disease 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 Putman

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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Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Levofloxacin Premarket Notification K972688 - Amendment 1 August 29, 1997

# Intended Use Statement

510(k) No .:

K972688

Device Name:

MicroScan® Dried Gram-Positive MIC/Combo Panels with Levofloxacin (0.015-32 µg/ml)

Indications for Use:

To determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin. Organisms with indications for testing* include:

Levofloxacin Gram-Positive Bacteria Enterococcus faecalis Staphylococcus aureus Streptococcus pyogenes

* As taken from the Indications and Usage section of the manufacturers' package insert (Ortho-McNeil).

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\/ for Prescription Use

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