DRIED GRAM-NEGATIVE MIC/COMBO PANELS

K970676 · Dade Intl., Inc. · JWY · May 2, 1997 · Microbiology

Device Facts

• Record ID: K970676
• Device Name: DRIED GRAM-NEGATIVE MIC/COMBO PANELS
• Applicant: Dade Intl., Inc.
• Product Code: JWY · Microbiology
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

To determine antimicrobial agent susceptibility

Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels determine minimum inhibitory concentrations (MIC) of Levofloxacin for Gram-negative bacteria; used in clinical microbiology laboratories. Device utilizes microdilution method; panels contain dried antimicrobial agents. Inoculation performed via Turbidity or Prompt methods; panels incubated and read using autoScan-4 or WalkAway instruments. Output provides MIC values to guide antibiotic therapy selection. Performance compared against NCCLS frozen reference panels to ensure clinical efficacy.

Clinical Evidence

Bench testing only. Evaluation used fresh and stock efficacy isolates and stock challenge strains. Compared MicroScan panels to NCCLS frozen reference panels. Reported 100% Essential Agreement. Reproducibility and precision testing conducted across Turbidity and Prompt inoculum methods and autoScan-4/WalkAway instruments. Quality control performance deemed acceptable.

Technological Characteristics

Microdilution panels with dried antimicrobial agents. Compatible with autoScan-4 and WalkAway automated reading instruments. Inoculation via Turbidity or Prompt methods.

Indications for Use

Indicated for determining antimicrobial susceptibility of Gram-negative bacteria to 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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Dade MicroScan Inc.
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin
Premarket Notification
February 21, 1997
K970670 MAY -2 1997

# DADE

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: [phone]
Date prepared: February 21, 1997
Product Name: Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name: MicroScan® Dried Gram-Negative 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-Negative 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 the new antimicrobial, Levofloxacin, for the MicroScan® Dried Gram-Negative MIC/Combo Panels.

The 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 MicroScan® Dried Gram-Negative Levofloxacin Panel by comparing their performance with an NCCLS frozen Levofloxacin Reference panel.

The MicroScan® Dried Gram-Negative Levofloxacin Panel demonstrated acceptable efficacy performance with an overall Essential Agreement of 100% when compared with the frozen Levofloxacin Reference panel.

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

Quality Control performance was acceptable for the MicroScan® Dried Gram-Negative Levofloxacin Panel.

LVX510k.DOC
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